Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0516 · 1 trial · 1 indication
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 (...
Top 20 of 53 competitors
AZD0516 is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is currently in Phase 1 clinical development as a monotherapy and in combination with other agents. The drug is being evaluated in a clinical trial enrolling male participants aged 18 years and older.
AZD0516 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 clinical trial of AZD0516 in participants with metastatic prostate cancer across multiple countries.
AZD0516 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to evaluate the safety and efficacy of AZD0516 as a monotherapy and in combination for metastatic prostate cancer.
AZD0516 is being studied in a Phase 1 clinical trial with the identifier NCT07181161. This trial, titled 'Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer,' is currently recruiting participants and has a target enrollment of 283 patients.
Yes, the Phase 1 clinical trial of AZD0516 is randomized and controlled. The trial is not double-blind, meaning participants and investigators know which treatment is being administered. The study is designed to evaluate AZD0516 as a monotherapy and in combination with other treatments for metastatic prostate cancer.
The AZD0516 Phase 1 clinical trial is being conducted in multiple countries, including the United States, Brazil, China, France, Italy, Japan, Poland, South Korea, Spain, and the United Kingdom. The trial is actively recruiting male participants aged 18 years and older with metastatic prostate cancer.