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["NCT Number","Study Title","Study URL","Study Status","Study Results","Conditions","Interventions","Primary Outcome Measures","Secondary Outcome Measures","Study Type","First Posted","Results First Posted","Last Update Posted"]
["NCT04506567","Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC","https://clinicaltrials.gov/study/NCT04506567","SUSPENDED","NO","Prostate Cancer","DRUG: 225Ac-J591|DIAGNOSTIC_TEST: 68Ga-PSMA-HBED-CC injection|DRUG: 225Ac-J591","Number of subjects with dose limiting toxicity (DLT), DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Will be collected at the time of visit 1 through end of study or 100 months|Cumulative maximum tolerated dose (MTD), The dose that produces an \"acceptable\" level of toxicity or that, if exceeded, would put subjects at \"unacceptable\" risk for toxicity. MTD is defined as the dose level at which no more than two patients out of six experienced dose-limiting toxicity (DLT)., Will be collected at the time of visit 1 through end of study or 100 months|Assess the recommended phase II dose (RP2D) of 225Ac-J591 in fractionated dose and multiple dose regimens (phase I), Will be collected at the time of visit 1 through end of study or 100 months|Assess the proportion of those with PSMA+ tumors with >50% PSA decline following 225Ac-J591 in two regimens (phase II), Proportion of patients achieving 50% or greater PSA decline (relative to baseline/pre-treatment PSA). Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy., Will be collected at the time of visit 1 through end of study or 100 months","Number of subjects with radiographic response, Response evaluation criteria in solid tumors RECIST (Version 1.1) criteria with prostate cancer working group 3 (PCWG3) modifications will be used, Scans will be performed at screening, day 85, then again at end of study or 100 months|Overall survival following fractionated dose and multiple doses of 225Ac-J591, Overall survival will be captured through in-clinic or telephone contact with subjects, Survival will be collected from Day 1 through study completion up to 100 months|Change in disease assessment with 68Ga-PSMA-11 PET/CT prior to and following investigational treatment, 68Ga-PSMA-11 PET/CT will be utilized as part of the radiographic assessment., Scans will be performed at screening, day 85 and day 168|Change in circulating tumor cells (CTC) and the rate of favorable and undetectable CTC count at 12 weeks following 225Ac-J591, CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing, Samples will be collected at screening, day 1, day 85 and at disease progression|Safety of treatment and adverse event rate, National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to grade all adverse events, Will be collected at the time of visit 1 through end of study or 100 months|Assess biochemical progression-free survival, PSA progression will be defined as a rise of \\> 25% above either the pretreatment level or the nadir PSA level (whichever is lowest). PSA must increase by \\> 2 ng/ml to be considered progression, Will be collected at the time of visit 1 through end of study or 100 months|Assess the proportion with different levels of PSA decline following 225Ac-J591, PSA will be monitored through serial blood draws. Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy., Will be collected at the time of visit 1 through end of study or 100 months","INTERVENTIONAL","2020-08-10"]
["NCT04576871","Re-treatment 225Ac-J591 for mCRPC","https://clinicaltrials.gov/study/NCT04576871","ACTIVE_NOT_RECRUITING","NO","Prostate Cancer","DRUG: 225Ac-J591","Change in the proportion of subjects in assessing safety of 225Ac-J591 in those previously treated with PSMA-TRT., Proportion of subjects with dose-limiting toxicity (DLT) from treatment cycle 1 to the end of the safety evaluation period at the end of the study. Acceptable safety is determined if no more than 2 (33%) of the subjects in a cohort experience DLT., Will be collected at the time of visit 1 through end of study or 100 months","Change in the number of subject with Prostate Specific Antigen (PSA) decline following 225Ac-J591 administration, PSA will be analyzed through blood specimen collection, Will be collected at the time of visit 1 through end of study or 100 months|Change in adverse event rate response, National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to grade all adverse events, Will be collected at the time of visit 1 through end of study or 100 months|Change in the number of subjects with dose limiting toxicity (DLT), DLTs will be measured by the recommended phase I fractionated dose and multiple dose regimens of 225Ac-J591 dose by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Will be collected at the time of visit 1 through end of study or 100 months|Change in radiographic response rate, Radiographic response rate will be captured through radiographic scans such as MRI, CT and bone scans. Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications, Will be collected at the time of visit 1 through end of study or 100 months|Change in circulating tumor cells (CTC) response, CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing, Will be collected at the time of visit 1 through end of study or 100 months|Change in progression-free survival following re-treatment doses of 225Ac-J591, Will be collected at the time of visit 1 through end of study or 100 months|Change in Overall Survival Following re-Treatment Doses of 225Ac-J591, Overall survival will be captured through in-clinic or telephone contact with subjects, Survival will be collected at the time of visit 1 through end of study or 100 months","INTERVENTIONAL","2020-10-06"]
["NCT03746431","A Phase 1/2 Study of [225Ac]-FPI-1434 Injection","https://clinicaltrials.gov/study/NCT03746431","RECRUITING","NO","Advanced Solid Tumours|Endometrial Cancer|Cervical Cancer|Ovarian Cancer|Breast Cancer|Triple Negative Breast Cancer (TNBC)|HER2-negative Breast Cancer|Head and Neck Squamous Cell Carcinoma (HNSCC)|Adrenocortical Carcinoma|Uveal Melanoma","DRUG: [111In]-FPI-1547 Injection|DRUG: [225Ac]-FPI-1434 Injection multi-dose|BIOLOGICAL: FPI-1175 Infusion|DRUG: [225Ac]-FPI-1434 Injection single-dose","Dose Escalation: Incidence of adverse events (AEs)., Phase 1, Approximately one year post final [225Ac]-FPI-1434 Injection.|Single-Dose Escalation: Incidence of dose limiting toxicities (DLTs)., Phase 1, 8 weeks.|Multi-Dose Escalation: Incidence of DLTs., Phase 1, 6 weeks.|Dose Escalation: Incidence of clinically significant clinical laboratory abnormalities., Phase 1, Approximately one year post final [225Ac]-FPI-1434 Injection.|Dose Escalation: Changes in electrocardiogram (ECG) parameters (PR, QRS, QT, and QTc intervals)., Phase 1, 4 weeks post final [225Ac]-FPI-1434 Injection.|Cold Antibody Sub-Study: Changes in uptake of [111In]-FPI-1547 Injection following FPI-1175 Infusion in selected regions of interest on SPECT/CT images., Phase 1, Within two weeks of the first [111In]-FPI-1547 Injection.|Cold Antibody Sub-Study: Changes in radiation dose estimates for selected tissues, organs and whole body both for [111In]-FPI-1547 and [225Ac]-FPI-1434 Injection at various dose levels following FPI-1175 Infusion., Phase 1, Within two weeks of the first [111In]-FPI-1547 Injection.|Evaluate anti-tumour activity of [225Ac]-FPI-1434 regimen, Phase 2, Approximately one year post final [225Ac]-FPI-1434 injection.|Objective response rate (ORR) RECIST v1.1., Phase 2, Approximately one year post final [225Ac]-FPI-1434 Injection.","Dose Escalation and Cold Antibody Sub-Study: Tumour uptake of [111In]-FPI-1547 in selected regions of interest on SPECT/CT images., Phase 1 and 2, Dose Escalation: Within one week of the [111In]-FPI-1547 Injection. Cold-Antibody Sub-Study: Within two weeks of the first [111In]-FPI-1547 Injection.|Dose Escalation: Radiation doses for selected organs and whole body both for [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection., Phase 1 and 2, Within one week of the [111In]-FPI-1547 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Changes in radiation absorbed doses for tumour lesions for [225Ac]-FPI-1434., Phase 1 and 2, Dose Escalation: Within one week of the [111In]-FPI-1547 Injection. Cold-Antibody Sub-Study: Within two weeks of the first [111In]-FPI-1547 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Clearance for radioactivity and for the targeting antibody., Phase 1 and 2, 4 weeks post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Area under the curve (AUC) for radioactivity and for the targeting antibody., Phase 1 and 2, 4 weeks post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Cmax for radioactivity and for the targeting antibody., Phase 1 and 2, 4 weeks post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Half-life for radioactivity and for the targeting antibody., Phase 1 and 2, 4 weeks post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Objective response rate (ORR) (sum of complete and partial response) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group 3 (PCWG3) guidelines., Phase 1, Approximately one year post final [225Ac]-FPI-1434 Injection.|Dose Escalation: Changes in the corrected QT (QTc) interval in milliseconds after [225Ac]-FPI-1434 treatment, compared to baseline., Phase 1 and 2, Approximately 24 hours from the time of [225Ac]-FPI-1434 Injection administration.|Dose Escalation and Cold-Antibody Sub-Study: Changes in human growth hormone (hGh) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection., Phase 1 and 2, 4 weeks post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Changes in insulin-like growth factor 1 (IGF-1) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection., Phase 1 and 2, 4 weeks post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Changes in insulin-like growth factor binding protein 3 (IGFBP-3) following [111In]-FPI-1547 Injection and [225Ac]-FPI-1434 Injection., Phase 1 and 2, 4 weeks post final [225Ac]-FPI-1434 Injection.|Cold Antibody Sub-Study: Incidence of AEs., Phase 1 and 2, Approximately one year post final [225Ac]-FPI-1434 Injection.|Cold Antibody Sub-Study: Incidence of clinically significant clinical laboratory abnormalities., Phase 1 and 2, Approximately one year post final [225Ac]-FPI-1434 Injection.|Cold Antibody Sub-Study: Changes in ECG parameters (PR, QRS, QT, and QTc intervals)., Phase 1 and 2, 4 weeks post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Time to response (TTR)., Phase 1 and 2, Approximately one year post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Duration of response (DoR)., Phase 1 and 2, Approximately one year post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Progression free survival (PFS)., Phase 1 and 2, Approximately one year post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Time to Progression (TTP)., Phase 1 and 2, Approximately one year post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Disease control rate (DCR)., Phase 1 and 2, Approximately one year post final [225Ac]-FPI-1434 Injection.|Dose Escalation and Cold-Antibody Sub-Study: Overall survival (OS)., Phase 1 and 2, Approximately one year post final [225Ac]-FPI-1434 Injection.","INTERVENTIONAL","2018-11-19"]
["NCT04886986","Phase I/II 225Ac-J591 Plus 177Lu-PSMA-I&T for Progressive Metastatic Castration Resistant Prostate Cancer","https://clinicaltrials.gov/study/NCT04886986","SUSPENDED","NO","Prostate Cancer","DRUG: 225Ac-J591|DRUG: 177Lu-PSMA-I&T|DRUG: 68Ga-PSMA-11","Proportion of subjects with dose limiting toxicity (DLT) of 225Ac-J591 and 177Lu-PSMA-I&T during dose-escalation phase., DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Will be collected at the time of visit 1 through end of study or 100 months|Cumulative maximum tolerated dose (MTD) and recommended phase II dose 225Ac-J591 and 177Lu-PSMA I&T, The dose that produces an \"acceptable\" level of toxicity or that, if exceeded, would put subjects at \"unacceptable\" risk for toxicity. Definition of the MTD usually relies on the sample, as MTD is defined as the dose level at which no more than one patient out of six experienced dose-limiting toxicity (DLT)., Will be collected at the time of visit 1 through end of study or 100 months|Proportion of PSMA+ subjects (by imaging criteria) with PSA decline following treatment with the combination of 225Ac-J591 and 177Lu-PSMA I&T., Proportion of patients achieving 50% or greater PSA decline (relative to baseline/pre-treatment PSA). Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy., Will be collected at the time of visit 1 through end of study or 100 months","Change in biochemical progression-free survival, PSA progression will be defined as a rise of \\> 25% above either the pretreatment level or the nadir PSA level (whichever is lowest). PSA must increase by \\> 2 ng/ml to be considered progression., Will be collected at the time of visit 1 through end of study or 100 months|Change in circulating tumor cells (CTC) count, CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing, Samples will be collected at screening, week 12, week 24.|Number of subjects with radiographic response rate, Response evaluation criteria in solid tumors RECIST (Version 1.1) criteria with prostate cancer working group 3 (PCWG3) modifications will be used., Patients will undergo imaging at screening, week 12, and week 24.|Safety of treatment and adverse event rate, National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to grade all adverse events, Will be collected at the time of visit 1 through end of study or 100 months.|Overall survival following treatment with 225Ac-J591 and 177Lu-PSMA-I&T, Overall survival will be captured through in-clinic or telephone contact with subjects, Survival will be collected from Day 1 through study completion up to 100 months|Change in disease assessment with 68Ga-PSMA-11 PET/CT prior to and following investigational treatment, 68Ga-PSMA-11 PET/CT will be utilized as part of the radiographic assessment., Patients will undergo imaging at screening, week 12, and week 24.","INTERVENTIONAL","2021-05-14"]
["NCT04946370","Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer","https://clinicaltrials.gov/study/NCT04946370","RECRUITING","NO","Prostate Cancer","DRUG: 225Ac-J591|DRUG: Pembrolizumab|DRUG: Androgen receptor pathway inhibitor|DIAGNOSTIC_TEST: 68Ga-PSMA-11","Proportion of patients with dose-limiting toxicity (DLT) following treatment with pembrolizumab and 225Ac-J591, Primary outcome for phase I; DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. There will be 12 weeks of safety follow-up following visit 1., From visit 1 through 12 weeks on study|Determination of optimal dose of 225Ac-J591 for phase II, Primary outcome for phase I; following 12 weeks of safety follow-up, the study team will make a determination of the 225Ac-J591 dose for phase II (either 65 or 90 KBq/kg)., From visit 1 through 12 weeks on study|Change in composite response rate of pembrolizumab and ARPI with or without 225Ac-J591, The primary outcome for phase II will be response, a composite of: PSA decline greater than 50% of baseline, measurable disease response by imaging criteria, conversion of circulating tumor cell count to favorable or undetectable., Will be collected at the time of visit 1 and up to 100 months","Change in overall survival following treatment, Overall survival will be captured through in-clinic or telephone contact with subjects, Survival will be collected from Day 1 and up to 100 months|Change in biochemical progression-free survival, PSA progression will be defined as a rise of \\> 25% above either the pretreatment level or the nadir PSA level (whichever is lowest). PSA must increase by \\> 2 ng/ml to be considered progression., Will be collected at the time of visit 1 and up to 100 months|Change in radiographic progression-free survival, Response evaluation criteria in solid tumors RECIST (Version 1.1) criteria with prostate cancer working group 3 (PCWG3) modifications will be used., Patients will undergo imaging at screening and then every 12 weeks, for up to 100 months|Change in proportion with 1-year progression-free survival, By imaging (RECIST 1.1 criteria with prostate cancer working group 3 modifications) or biochemical (PSA) criteria, Will be collected at the time of visit 1 through 1 year on study|Change in proportion with >30% PSA decline, Baseline (pre-treatment) PSA levels will be compared to PSA nadir on study, Will be collected at the time of visit 1 and up to 100 months|Change in proportion with >50% PSA decline, Baseline (pre-treatment) PSA levels will be compared to PSA nadir on study, Will be collected at the time of visit 1 and up to 100 months|Change in proportion with >90% PSA decline, Baseline (pre-treatment) PSA levels will be compared to PSA nadir on study, Will be collected at the time of visit 1 and up to 100 months","INTERVENTIONAL","2021-06-30"]
["NCT05363111","Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma","https://clinicaltrials.gov/study/NCT05363111","RECRUITING","NO","Recurrent Plasma Cell Myeloma|Refractory Plasma Cell Myeloma","BIOLOGICAL: Actinium Ac 225-DOTA-Daratumumab|BIOLOGICAL: Daratumumab|BIOLOGICAL: Indium In 111-DOTA-Daratumumab","Incidence of dose-limiting toxicities (DLTs), Toxicity will be graded according to the National Cancer Institute (NCI)- Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., During the first 6 weeks post administration of study drug|Maximum tolerated dose (MTD), Toxicity will be graded according to the NCI-CTCAE version 5.0. The MTD is defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. The MTD will be based on the assessment of DLT during the first 6 weeks., During the first 6 weeks post administration of study drug","Overall response rate, Will be defined as the proportion of patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR). Disease response will be evaluated per International Myeloma Working Group (IMWG) response criteria., Up to 12 months|Complete response rate, Will be defined as the proportion of patients meeting the criteria for CR or sCR., Up to 12 months|12-month overall survival, If a patient is still alive, survival time is censored at the time of last follow-up., Time from first day of treatment to time of death due to any cause, assessed up to 12 months|Progression free survival, If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Patients who start a new treatment regimen without documented progression will be censored., Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 12 months|Time to progression, If failure has not occurred, failure time is censored at the time of last follow-up., Time from first day of treatment to the first observation of disease progression or death due to disease, assessed up to 12 months|Duration of response, Deaths from causes other than progression will be censored and not included in calculation., In patients with PR or better, time from first response documented until disease progression, assessed up to 12 months","INTERVENTIONAL","2022-05-05"]
["NCT05605522","A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours","https://clinicaltrials.gov/study/NCT05605522","RECRUITING","NO","Pancreatic Ductal Adenocarcinoma (PDAC)|Squamous Cell Carcinoma of Head and Neck|Colorectal Cancer|Gastric Cancer|Ewing Sarcoma|NTSR1 Expressing Solid Tumours|Neuroendocrine Differentiated (NED) Prostate Cancer","DRUG: [225]-FPI-2059|DRUG: [111In]-FPI-2058","Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058, approximately 5 years post final administration|Maximum tolerated dose (MTD) of [225Ac]-FPI-2059, 56 days post administration|Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest, within 56 days of administration","Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1, approximately 5 years post final administration|Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images, within 56 days of administration|Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life, approximately 36 days of final administration","INTERVENTIONAL","2022-11-04"]
["NCT04597411","Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer","https://clinicaltrials.gov/study/NCT04597411","RECRUITING","NO","Prostatic Neoplasms, Castration-Resistant","RADIATION: 225^Ac-PSMA-617|RADIATION: 68^Ga-PSMA-11","Recommended Phase 2 Dose (RP2D), The RP2D for each group (Group A, B and C) is defined as the dose level that is well tolerated (i.e., at or below the MTD) and for which there may be additional findings (e.g., longer term tolerability) effecting the RP2D decision. In the case where an MTD is not identified, even at the highest dose level tested, the RP2D may be determined on the basis of data indicating adequate tolerability and therapeutic effectiveness., 6 weeks post Cycle 1 Day 1 (C1D1) of each dosing cohort through enrollment completion, an average of 1.5 years to determine RP2D","Percentage of Participants with treatment emergent adverse events, Safety measured by the percentage of participants with treatment emergent adverse events (events started after the first dose of study medication or events present prior to start of treatment but increased in severity based on preferred term)., Day 1/Infusion Day up to 60 days post infusion|Overall Response Rate (ORR), Overall Response Rate (ORR) is defined as the proportion of participants with best overall response of Complete Response (CR) or Partial Response (PR) as measured by RECIST v1.1., Every 8 weeks after first dose of 225Ac-PSMA-617 for the first 24 weeks, then every 12 weeks through the end of treatment visit, on average 2.5 years|Duration of Response (DOR), Duration of Response (DOR) is the time from the date of the first documented response (CR or PR) to the date of the first radiologically documented disease progression or death due to disease according to RECIST v1.1., Every 8 weeks after first dose of 225Ac-PSMA-617 for the first 24 weeks, then every 12 weeks through the end of treatment visit, on average 2.5 years|Disease Control Rate (DCR), Disease Control Rate (DCR) is the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1., Every 8 weeks after first dose of 225Ac-PSMA-617 for the first 24 weeks, then every 12 weeks through the end of treatment visit, on average 2.5 years|Progression Free Survival (PFS), Progression Free Survival (PFS) is defined as the time from Cycle 1 Day 1 (C1D1) to the first of radiographic, clinical, or prostate-specific antigen \\[PSA\\] progression-free survival, or censorship with events defined as follows:\n\n1. Radiographic disease progression as determined from bone scans and contrast CT/MRI as outlined in Prostate Cancer Working Group 3 (PCWG3) and RECIST 1.1\n2. Unequivocal clinical progression\n3. PSA progression, defined as the date that a â‰¥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir is documented and confirmed by a second consecutive value obtained 3 or more weeks later. Rises in PSA within the first 12 weeks will be ignored. Where no decline from baseline is documented, baseline PSA is the nadir. The date of progression is date of first occurrence, not date of confirmation (PCWG3 Guidance)., Every 8 weeks after first dose of 225Ac-PSMA-617 for the first 24 weeks, then every 12 weeks through the end of treatment visit, on average 2.5 years|Percentage of Participants with Biochemical Response as measured by Prostate Specific Antigen (PSA), Prostate-specific antigen is a glycoprotein considered as a biomarker for the response to therapy in men with prostate cancer. A 50 percent (%) decline in PSA from Baseline to the PSA level at End of Study was considered as a PSA response., Baseline, Days 1, 15, 29 and 43 of each Cycle (1 cycle = 8 weeks +/- 1 week), End of Treatment and every 3 months during the 12-month follow-up period|Notable Changes in Alkaline phosphatase (ALP) levels, Safety measured by the notable post-baseline changes in Alkaline phosphatase (ALP) levels compared to baseline., Baseline, Cycle 1 and Cycle 2 (Weekly), Cycle 3 to Cycle 6 (Bi-weekly) (1 cycle = 8 weeks +/- 1 week)|Notable Changes in Lactate dehydrogenase (LDH) levels, Safety measured by the notable post-baseline changes in Lactate dehydrogenase (LDH) levels compared to baseline., Baseline, Cycle 1 and Cycle 2 (Weekly), Cycle 3 to Cycle 6 (Bi-weekly) (1 cycle = 8 weeks +/- 1 week)|Change from Baseline in European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D-5L), EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions., Baseline, Day 1 of each Cycle (1 cycle = 8 weeks +/- week), End of Treatment, on average 2.5 years|Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire, FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACT-General (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life., Baseline, Day 1 of each Cycle (1 cycle = 8 weeks +/- week), End of Treatment, on average 2.5 years|Change from Baseline in Brief Pain Inventory - Short Form (BPI-SF) Questionnaire: Pain Severity Score, The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 \\[no pain\\] to 10 \\[pain as bad as you can imagine\\]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use., Baseline, Day 1 of each Cycle (1 cycle = 8 weeks +/- week), End of Treatment, on average 2.5 years|Change from Baseline in Brief Pain Inventory - Short Form (BPI-SF) Questionnaire: Pain Interference Score, The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain interference score is mean value for the 7 BPI-SF questions (questions inquiring about the extent of interference with activities by pain) where the extent is ranked from 0 (does not interfere) to 10 (completely interferes). Pain interference progression is defined as an increase in score of 50% or greater from baseline without decrease in analgesic use., Baseline, Day 1 of each Cycle (1 cycle = 8 weeks +/- week), End of Treatment, on average 2.5 years|Change from Baseline in Xerostomia-Related Quality of Life Scale (XeQOLS), The XeQOLS is a validated patient reported 15-item assessment scale with 4 domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. A negative change from Baseline indicates an improvement of the xerostomia burden., Baseline, Day 1 of each Cycle (1 cycle = 8 weeks +/- 1 week), End of Treatment and every 3 months during the 12-month follow-up period","INTERVENTIONAL","2020-10-22"]
["NCT05204147","Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers","https://clinicaltrials.gov/study/NCT05204147","RECRUITING","NO","Advanced Cancer|Metastatic Cancer","DRUG: Actinium Ac 225-DOTA-anti-CEA Monoclonal Antibody M5A|PROCEDURE: Biospecimen Collection","Incidence of adverse events, The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by National Cancer Institute Common Toxicity Criteria and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), and attribution to study drug. Tables will be created to summarize these toxicities and side effects by dose and by course., Up to 6 months|Maximum tolerated dose (MTD), The MTD is defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicities (DLT) attributable to the study drugs, when at least six patients were treated at that dose and are evaluable for toxicity. The MTD is one dose level below the DLT-level. At least 6 patients will be treated at the MTD., Up to 36 months","Overall survival, From first day of treatment to time of death due to any cause., Assessed up to 6 months|Progression-free survival, From first day of treatment to the first observation of disease progression or death due to any cause., Assessed up to 6 months|Time to failure, From first day of treatment to the first observation of disease progression or death due to disease., Assessed up to 6 months|Best overall response, Evaluated with complete response, partial response, progressive disease or stable disease. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of measurement criteria, but confirmation is not necessary., Up to 6 months","INTERVENTIONAL","2022-01-24"]
["NCT05595460","Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC","https://clinicaltrials.gov/study/NCT05595460","RECRUITING","NO","SCLC,Extensive Stage","DRUG: RYZ101 Dose Level 1|DRUG: RYZ101 Dose Level 2|DRUG: RYZ101 Dose Level 3|DRUG: RYZ101 Dose Level -1|DRUG: Atezolizumab|DRUG: Carboplatin|DRUG: Etoposide","RP2D, RP2D as determined by incidence rate of DLTs, 42 days of study treatment|Safety and tolerability of RYZ101 in combination with SoC, Safety and tolerability of RYZ101 in combination with SoC as measured by incidence and severity of AEs including SAEs, laboratory changes and other safety findings, Up to 50 months","","INTERVENTIONAL","2022-10-27"]
["NCT05219500","Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST).","https://clinicaltrials.gov/study/NCT05219500","RECRUITING","NO","Metastatic Castration Resistant Prostate Cancer","DRUG: FPI-2265","To evaluate the effect of FPI-2265 on prostate-specific antigen (PSA) in participants with mCRPC., Frequency and proportion of participants with PSA50, defined as â‰¥ 50% decline in PSA level by 12-weeks after the first treatment., From start of treatment until 12 weeks after the first treatment.","To evaluate the safety and tolerability of FPI- 2265., * Frequency, duration and severity of treatment emergent adverse events (TEAEs) evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).\n* Changes in clinical laboratory, electrocardiograms (ECGs) and physical examinations compared to baseline., From first treatment dose to up to 24 months after last treatment.|To evaluate the anti-tumor activity of FPI-2265., * Maximum % PSA decline.\n* PSA progression free survival (PFS).\n* Time to best PSA response\n* Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Disease control rate (DCR) per RECIST v1.1.\n* Duration of response (DoR) based on RECIST v1.1/Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.\n* Radiographic progression-free survival (rPFS) per PCWG3 criteria.\n* Overall survival (OS)., From first treatment until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 24 months after last treatment.|To assess the impact of FPI-2265 on participant reported outcomes., * The frequency and proportion of participants with an improvement in bone pain levels.\n* Change in quality of life (QoL) over time., From first treatment until 24 months after last treatment.","INTERVENTIONAL","2022-02-02"]
["NCT03441048","Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia","https://clinicaltrials.gov/study/NCT03441048","COMPLETED","NO","Acute Myeloid Leukemia","BIOLOGICAL: Lintuzumab-Ac-225|DRUG: Cladribine|DRUG: Cytarabine|DRUG: Mitoxantrone|DRUG: G-CSF","The number of subjects with dose-limiting toxicities., Dose-escalation will be conducted according to a 3+3 design with a five-patient expansion cohort at the recommended phase 2 dose. The initial dose of Lintuzumab-Ac225 will be 0.25 micro-Curie (Î¼Ci)/kg (Dose level 1), and the highest dose administered will be 1.25 Î¼Ci/kg.\n\n* if 0/3 pts have no dose-limiting toxicity (DLT), new patients enter next dose level.\n* if 1/3 pts has DLT, 3 pts treated at same dose level.\n* if 0/3 pts at that dose level has DLT, new pts enter higher level.\n* if 1 or more of the additional 3 pts has a DLT, no further pts started at dose level, preceding dose is the MTD.\n* if 2/3 of initially dosed patients have a DLT on first dose, study terminated.\n* if 0/3 have DLT at highest dose, additional 3 enrolled., 28 Days|Maximum-tolerated dose., Defined as the dosage with the highest level at which no more than one subject experiences a DLT., 28 Days|The number of subjects who have at least one serious adverse event related to the study., All subjects who receive study drug will be closely monitored for serious adverse events (SAEs). The NCI's CTCAE (Common Toxicity Criteria for Adverse Effects) v4.03 will be used., 60 days|Overall survival, The number of subjects alive at two years from the first day of salvage therapy., 2 years","The number of subjects with a complete response (CR)., A complete response will be defined as bone marrow blasts \\<5% with absolute neutrophil count â‰¥1000/Î¼L and platelet â‰¥100,000/Î¼L., Up to Day 60|The number of subjects with CR with incomplete hematologic recovery (CRi), CRi is defined as CR without platelet recovery or neutrophil recovery. This will be defined as bone marrow blasts \\<5% with absolute neutrophil count \\<1000/L and platelet \\<100,000/L., Up to Day 60|The number of subjects in a morphologic leukemia-free state (MLFS)., MLFS is bone marrow blasts \\<5% with absolute neutrophil count \\<1000/Î¼L AND platelet \\<100,000/Î¼L., Up to Day 60|The number of subjects experiencing partial remission., Partial remission (PR) is defined by a decrease of at 50% or more in the percentage of blasts to less than 25% in the bone marrow. and normalized blood counts ( ANC\\>1000, Platelets\\>100,000/ml)., Up to Day 60|Progression-free Survival, The number of subjects, who from the first day of remission until one year, do not relapse or progress., 1 Year","INTERVENTIONAL","2018-02-22"]
["NCT05567770","ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer","https://clinicaltrials.gov/study/NCT05567770","WITHDRAWN","NO","Prostate Cancer Metastatic","DRUG: Actinium-J591|RADIATION: Stereotactic Body Radiation Therapy|DRUG: Androgen Deprivation Therapy","Dose Limiting Toxicity (DLT) Rate, A DLT will is defined as a grade 3 or higher hematologic adverse event or a grade 2 or higher non-hematologic adverse event deemed to be at least possibly related to study treatment. Adverse events will be assessed using CTCAE version 5. Patients will be observed for a DLT for 3 months from the second dose of actinium-J591., 24 months|Change in Maximum Tolerated Dose (MTD), 3,6,12,18 and 24 months.","Progression Free Survival (PFS) on conventional Imaging, 3 months|Progression Free Survival (PFS) on conventional Imaging, 6 months|Progression Free Survival (PFS) on conventional Imaging, 12 months|Progression Free Survival (PFS) on conventional Imaging, 24 months|Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging., 3 months|Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging., 6 months|Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging., 12 months|Progression Free Survival (PFS) on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging., 24 months|Changes in PSMA expression measured by comparison of SUV on PSMA PET scans before and after treatment, 3, 6, 12, and 24 months|Change in Percentage of PSA decline, 3, 6, 12, 15, 18, 21, and 24 months.","INTERVENTIONAL","2022-10-05",null,"2023-08-24"]
["NCT05477576","Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy","https://clinicaltrials.gov/study/NCT05477576","RECRUITING","NO","GEP-NET|Gastroenteropancreatic Neuroendocrine Tumor|Gastroenteropancreatic Neuroendocrine Tumor Disease|Neuroendocrine Tumors|Carcinoid|Carcinoid Tumor|Pancreatic NET","DRUG: RYZ101|DRUG: Everolimus|DRUG: Sunitinib|DRUG: Octreotide|DRUG: Lanreotide","Phase 1b: RP3D, Incidence of DLTs during the first 56 days of study treatment will be assessed., 56 days of study treatment|Phase 3: PFS as determined by BICR, PFS will be defined as the time from the date of randomization until the date of progression (as determined by BICR from tumor assessments using RECIST v1.1) or death due to any cause, whichever occurs earlier., After the target number of 143 PFS events have occurred","","INTERVENTIONAL","2022-07-28",null,"2025-06-27"]
["NCT04644770","A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer","https://clinicaltrials.gov/study/NCT04644770","RECRUITING","NO","Prostatic Neoplasms|Adenocarcinoma","DRUG: JNJ-69086420|DRUG: JNJ-78278343|RADIATION: Stereotactic body radiation therapy","Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability, An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study., Up to 2 years and 4 months|Part 1: Number of Participants with Dose-Limiting Toxicity (DLT), Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity., Up to 2 years and 4 months|Number of Participants with AEs by Severity, Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event., Up to 2 years and 4 months","Percentage of Participants with Prostate Specific Antigen (PSA) Response, PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline and that is subsequently confirmed., Up to 2 years and 4 months|Overall Response Rate (ORR), ORR is defined as the percentage of participants who have a Partial Response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3)., Up to 2 years and 4 months|Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420, Cmax is defined as the maximum observed serum concentration/radioactivity of JNJ-69086420., Up to 2 years and 4 months|Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420, Tmax is defined as time to reach maximum observed serum concentration/radioactivity of JNJ-69086420., Up to 2 years and 4 months|Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420, AUC(0-t) is defined as the area under the serum concentration-time curve from time zero to t of JNJ-69086420., Up to 2 years and 4 months|Number of Participants With Anti-JNJ-69086420 Antibodies, Number of participants with anti-JNJ-69086420 antibodies will be assessed to evaluate the potential immunogenicity., Up to 2 years and 4 months|Part 3: Serum Concentration of JNJ-78278343, Venous blood samples will be collected for assessment of serum concentrations of JNJ-78278343., Up to 2 years and 4 months|Part 3:Number of Participants With Anti-JNJ-78278343 Antibodies, Number of participants with anti-JNJ-78278343 antibodies will be assessed to evaluate the potential immunogenicity., Up to 2 years and 4 months","INTERVENTIONAL","2020-11-25",null,"2025-07-18"]
["NCT03867682","Venetoclax and Lintuzumab-Ac225 in AML Patients","https://clinicaltrials.gov/study/NCT03867682","RECRUITING","NO","Acute Myeloid Leukemia|Relapsed Adult AML","BIOLOGICAL: Lintuzumab-Ac225|DRUG: Venetoclax|DRUG: Spironolactone","Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225, To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapse/refractory AML., Cycle 1, up to 48 days|Phase II: Overall Response (CR + CRh + CRi), To assess the percentage of patients with CR, CRh, CRi or Overall Response (CR + CRh + CRi), up to 6 months after the start of treatment without receiving other AML therapies., Up to 6 months","Phase I: Overall Response, Number of patients who's overall response is CR, CRh, or CRi, Up to 6 months|Phase I and II: OS, Number of patients who died, End of 6 months, 12 months, 2 years|Phase I and II: DFS, Disease-free survival, End of 6 months, 12 months, 2 years|Phase I and II: Evaluate incidence of AEs and SAEs, Rate of AEs and SAEs, including infusion-related reactions, Through study completion, up to 2 years|Phase I and II: Evaluate BH3 priming assay results, Summary of assay results, Completion of Cycle 1, estimated 1 month|Phase I and II: MRD status, Number of patients who are MRD negative, From date of first dose until the date of first documented response, first assessment at 6 months|Phase I and II: Lab abnormalities (other than hematologic indices), Summary of rate of Grade 3/4 lab abnormalities, Through study completion, up to 2 years","INTERVENTIONAL","2019-03-08",null,"2023-08-04"]
["NCT03276572","Phase I Trial of 225Ac-J591 in Patients With mCRPC","https://clinicaltrials.gov/study/NCT03276572","COMPLETED","YES","Prostate Cancer","DRUG: 225Ac-J591","Number of Subjects With Dose Limiting Toxicities (DLT), Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs., Assessed from start of treatment to up to 8 weeks after first study drug administration.|Number of Subjects Who Reached Maximum Tolerated Dose (MTD), The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT., Assessed from start of treatment to up to 8 weeks after first study drug administration.","Number of Subjects With Prostate Specific Antigen (PSA) Response, PSA will be analyzed through blood specimen collection, PSA was assessed at screening, and up to 6 months after first treatment with study drug.|Number of Subjects With Circulating Tumor Cells (CTC) Response, CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing, CTC was assessed at screening and 12 weeks after starting study drug.|Number of Subjects With Radiographic (Imaging) Response, Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications, Response were assessed for patients throughout their duration on the study, up to 3 years.|Progression Free Survival (PFS), Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions., From the start of treatment to progression, up to 3 years","INTERVENTIONAL","2017-09-08","2022-12-06","2024-06-13"]