Study on Tulmimetostat and Luxdegalutamide for Treating Progressive Metastatic Castrate Resistant Prostate Cancer
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT07206056
This clinical trial is testing a new combination of drugs, tulmimetostat and luxdegalutamide, to see if they are safe and effective in treating men with advanced prostate cancer that has spread and is resistant to standard hormone therapy.
Patient Parameters
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Program Overview
The study is divided into two parts. The first part (Phase I) focuses on finding the safest and most effective doses of the drug combination. The second part (Phase II) compares the new drug combination to the current standard treatment to see if it works better in reducing prostate cancer markers in the blood.
Description
In Phase I, the study is split into two sections:
- Part 1a: Researchers will test different doses of tulmimetostat and luxdegalutamide to find the best dose for further testing.
- Part 1b: Once the best dose is found, it will be tested further to confirm its effectiveness and safety.
In Phase II, the study will compare the new drug combination to the standard treatment to see if it is more effective in lowering prostate cancer markers in the blood of men with advanced prostate cancer that has not responded to previous treatments.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older.
- Must have a confirmed diagnosis of prostate cancer that has spread and is resistant to standard hormone therapy.
- Must have at least one tumor that can be seen on a scan taken within 28 days before starting the study.
- Must have a low level of testosterone in the blood.
- Must have previously tried and not responded to at least one advanced hormone therapy drug.
- For some parts of the study, participants may have had limited chemotherapy in the past.
Exclusion Criteria
- Have previously taken certain types of cancer drugs, like PRC2 inhibitors or protein degraders targeting the androgen receptor.
- Have allergies or cannot take any of the study drugs or similar drugs.
- Have taken any experimental drugs within 28 days before starting the study.
- Have had certain types of radiation therapy for prostate cancer, except in specific parts of the study.
- Have prostate cancer that is not currently causing symptoms or does not require treatment.
- Have had brain metastases unless they have been treated and are stable without symptoms or need for steroids. Those with treated leptomeningeal disease are eligible if stable and without neurological issues. Brain scans are required for those with a history of brain metastases.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sarah Cannon Research Institute | 80218 | Denver | Colorado |
| Sarah Cannon Research Institute | 32256 | Jacksonville | Florida |
| Wichita Urology Group PA | 67226 | Wichita | Kansas |
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