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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05848011 | A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer | PHASE2 | COMPLETED | 154 | — | — | Sep 28, 2023 | Mar 16, 2026 | May 22, 2026 | 61 | United States, Australia +8 |
The rPFS is defined as the time from the date of randomization to the date of first documented PD per Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Lorigerlimab + Docetaxel and Prednisone | EXPERIMENTAL | Lorigerlimab 6 mg/kg IV (up to 2 years) and docetaxel 75 mg/m\^2 IV every 3 weeks (up to 7 months) and prednisone 5 mg orally twice daily (up to 7 months). |
| Standard of care docetaxel and prednisone | OTHER | Docetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months) |
| Name | Type | Description |
|---|---|---|
| lorigerlimab | BIOLOGICAL | Lorigerlimab is a DART® molecule that binds PD-1 and CTLA-4 |
| docetaxel | DRUG | Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer |
| Prednisone | DRUG | A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer |
Inclusion Criteria: * Metastatic castration-resistant adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features. * Participants must have ≥ 1 metastatic (measurable or non-measurable per PCWG3) lesion. * Participant has prostate cancer pr...