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 | Not Yet 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 South Korea
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 South Korea