Study on the Safety and Effectiveness of AZD9750 for Metastatic Prostate Cancer, Alone or with Other Cancer Drugs
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07336446
This clinical trial is exploring how safe and effective a new drug, AZD9750, is for treating metastatic prostate cancer. The study will test AZD9750 by itself and in combination with another drug, saruparib, to see how well they work together.
Patient Parameters
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Program Overview
The ANDROMEDA study is a first-of-its-kind trial to test a new drug, AZD9750, in people with metastatic prostate cancer. The trial will look at how safe the drug is, how it behaves in the body, and how well it works. AZD9750 will be tested alone and with another drug called saruparib. The study is designed to be flexible, allowing researchers to test different combinations of treatments. Participants will continue treatment until their cancer progresses, they experience unacceptable side effects, or they choose to stop.
Description
This study is testing a new drug, AZD9750, for people with metastatic prostate cancer. The trial is divided into two main parts: Part A focuses on finding the right dose of AZD9750, either alone or with saruparib, while Part B aims to optimize and expand the dose for better results. The study will continue until the cancer progresses, side effects become too severe, or participants decide to stop. Researchers will monitor safety, how the drug moves and works in the body, and its effectiveness in shrinking tumors. Additional drug combinations may be tested as the study progresses.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of prostate cancer that has spread to other parts of the body.
- Low testosterone levels (≤ 50 ng/dL).
- Evidence of cancer progression, such as rising PSA levels, new bone lesions, or tumor growth on scans.
- Good overall health with a performance status score of 0 or 1.
- Adequate bone marrow and organ function.
- For Part A: Must have had at least one prior treatment with ARPI and possibly taxane-based chemotherapy.
- For Part B: Must have had one or two prior treatments with ARPI and possibly taxane-based chemotherapy, or only ARPI for the no-taxane group.
Exclusion Criteria
- Have a type of prostate cancer other than adenocarcinoma.
- Have cancer that has spread to the brain or spinal cord.
- Have significant heart problems or abnormal heart rhythms.
- Have serious cardiovascular diseases like heart failure or uncontrolled high blood pressure.
- Have active digestive issues that affect how the drug is absorbed.
- Have a known tendency to bleed easily.
- Have previously been treated with an AR-PROTAC drug.
Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 91010 | Duarte | California |
| Research Site | 94143 | San Francisco | California |
| Research Site | 33612 | Tampa | Florida |
| Research Site | 02114 | Boston | Massachusetts |
| Research Site | 63108 | St Louis | Missouri |
| Research Site | 29572 | Myrtle Beach | South Carolina |
| Research Site | 37203 | Nashville | Tennessee |
| Research Site | 84112 | Salt Lake City | Utah |
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