Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04946370 | Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer | PHASE1 | RECRUITING | 52 | — | — | Aug 12, 2021 | Dec 1, 2029 | Apr 21, 2026 | 4 | United States |
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.
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).
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.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab + 225Ac-J591 + ARI | EXPERIMENTAL | Patients will receive one dose of 225Ac-J591 (single dose, either 65 or 80 Kbq/kg) in combination with pembrolizumab (400mg every 6 weeks) and ARI (standard dose schedule, examples of ARI include enzalutamide, apalutamide, darolutamide). |
| Pembrolizumab + ARI | EXPERIMENTAL | Patients will receive pembrolizumab (400mg every 6 weeks) and ARI (standard dose schedule) without 225Ac-J591. |
| Name | Type | Description |
|---|---|---|
| 225Ac-J591 | DRUG | Alpha-emitter Actinium-225 conjugated to the anti-PSMA antibody J591. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered intravenously, 400mg every 6 weeks. Patients may receive maximum 18 cycles of therapy, approximately 2 years. |
| Androgen receptor inhibitor | DRUG | Patients will receive an oral androgen receptor inhibitor (ARI). Examples include enzalutamide, apalutamide, darolutamide. Dosing will be the standard dosing, as described by the package insert. |
| 68Ga-PSMA-11 | DIAGNOSTIC_TEST | \[185 ±74 MBq or 5 ±2 mCi\] intravenous during screening and 12 weeks. Imaging agent for PSMA PET/CT. |
Inclusion Criteria: * Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate adenocarcinoma. * A male participant must agree to use a contraception during the treatment period and for at least 4 months after the ...