Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD0516: AZD0516 will be administered via intravenous infusion.
AZD9574: AZD9574 will be administered orally.
Study summary
The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.
Eligibility
Primary outcome measure(s)
- Module 1 and 2: Parts A and B: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs) — From Day 1 up to approximately 3 years
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. - Module 1 and 2: Part A: Number of participants with Dose Limiting Toxicities (DLTs) — From Day 1 up to end of DLT period (approximately 21 days)
To assess the safety and tolerability of AZD0516 as monotherapy and in combination with anti-cancer agents. - Module 1: Parts B and C and Module 2: Part B: Percentage of participants with Prostate-Specific Antigen (PSA) 50 response rate — Up to approximately 2 years
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.
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Fayetteville | Arkansas | Recruiting |
| Research Site | Los Angeles | California | Recruiting |
| Research Site | Towson | Maryland | Suspended |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Ann Arbor | Michigan | Recruiting |
| Research Site | Detroit | Michigan | Recruiting |
| Research Site | Buffalo | New York | Suspended |
| Research Site | New York | New York | Recruiting |
| Research Site | Providence | Rhode Island | Recruiting |
| Research Site | Myrtle Beach | South Carolina | Recruiting |
| Research Site | Houston | Texas | Recruiting |
| Research Site | Barretos | Brazil | Not Yet Recruiting |
| Research Site | Porto Alegre | Brazil | Not Yet Recruiting |
| Research Site | São Paulo | Brazil | Not Yet Recruiting |
| Research Site | Changsha | China | Not Yet Recruiting |
| Research Site | Chengdu | China | Not Yet Recruiting |
| Research Site | Wuhan | China | Not Yet Recruiting |
| Research Site | Lyon | France | Withdrawn |
| Research Site | Montpellier | France | Withdrawn |
| Research Site | Saint-Herblain | France | Withdrawn |
| Research Site | Suresnes | France | Withdrawn |
| Research Site | Villejuif | France | Withdrawn |
| Research Site | Milan | Italy | Not Yet Recruiting |
| Research Site | Milan | Italy | Not Yet Recruiting |
| Research Site | Milan | Italy | Not Yet Recruiting |
| Research Site | Naples | Italy | Not Yet Recruiting |
| Research Site | Roma | Italy | Not Yet Recruiting |
| Research Site | Rozzano | Italy | Not Yet Recruiting |
| Research Site | Chūōku | Japan | Recruiting |
| Research Site | Kashiwa | Japan | Recruiting |
| Research Site | Kōtoku | Japan | Recruiting |
| Research Site | Koszalin | Poland | Not Yet Recruiting |
| Research Site | Piotrkow Trybunalski | Poland | Not Yet Recruiting |
| Research Site | Przemyśl | Poland | Not Yet Recruiting |
| Research Site | Seoul | South Korea | Not Yet Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Not Yet Recruiting |
| Research Site | Barcelona | Spain | Recruiting |
+ 12 more sites — see the full list on the official registry below.
More AstraZeneca trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07181161 on ClinicalTrials.gov ↗ ← All trials in France