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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05519449 | Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) | PHASE1 | RECRUITING | 272 | — | — | Sep 15, 2022 | Dec 1, 2028 | Jan 20, 2026 | 35 | United States, Australia |
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose. |
| Backfill Expansion | EXPERIMENTAL | IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable. |
| Monotherapy Expansion Parts A - D | EXPERIMENTAL | IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D). |
| Combination Expansion | EXPERIMENTAL | IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose |
| Name | Type | Description |
|---|---|---|
| JANX007 | BIOLOGICAL | JANX007 is dosed via IV in a 21- or 28-day cycle. |
| Darolutamide | DRUG | Darolutamide is dosed via oral tablets |
Inclusion Criteria: * Male ≥18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate * For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane cont...