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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07181161 | Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer | PHASE1 | RECRUITING | 177 | — | — | Oct 1, 2025 | Jan 18, 2029 | May 8, 2026 | 52 | United States, Brazil +8 |
Part A: To assess the safety and tolerability and to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) of AZD0516 as monotherapy and in combination with anti-cancer agents. Part B: To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents.
The PSA50 response rate is defined as the percentage of participants achieving ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result.
| Arm | Type | Description |
|---|---|---|
| Arm 1: AZD0516 monotherapy | EXPERIMENTAL | Participants with mCRPC will receive AZD0516 monotherapy. |
| Arm 2: AZD0516 + AZD9574 | EXPERIMENTAL | Participants with mCRPC will receive AZD0516 in combination with AZD9574. |
| Name | Type | Description |
|---|---|---|
| AZD0516 | DRUG | AZD0516 will be administered via intravenous infusion. |
| AZD9574 | DRUG | AZD9574 will be administered orally. |
Main Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted. * Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL). * Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (...