Study on Oral MRT-2359 with Apalutamide for Prostate Cancer
Sponsor: Monte Rosa Therapeutics, Inc
ClinicalTrials ID:NCT07745361
This clinical trial is testing a new oral medication, MRT-2359, combined with apalutamide, to see if it can lower PSA levels in patients with castration-resistant prostate cancer. The study also aims to evaluate the safety and effectiveness of this treatment combination.
Patient Parameters
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Program Overview
This study is exploring a new treatment for prostate cancer that no longer responds to standard hormone therapy. It involves taking two oral medications: MRT-2359, which is still being researched, and apalutamide, which is already used to treat prostate cancer. The main goal is to see if this combination can reduce levels of prostate-specific antigen (PSA), a marker of prostate cancer activity. Researchers will also check how safe and tolerable the treatment is and look at other signs of its effectiveness against cancer.
Description
This Phase 2 study is open to patients with prostate cancer that continues to grow despite hormone therapy. Participants will take MRT-2359 along with apalutamide to see if this combination can lower PSA levels, which are used to monitor prostate cancer. The study will also assess the safety and side effects of the treatment, as well as how the body processes the drugs. Researchers will look at how the treatment affects the cancer and gather data on how the drugs work together.
Eligibility Criteria
Inclusion Criteria
- Must be over 18 years old.
- Expected to live at least 3 more months and be in good general health (ECOG score of 0 or 1).
- Have prostate cancer that no longer responds to hormone therapy, confirmed by lab tests, and has specific genetic changes.
- Have not had more than one previous chemotherapy treatment with taxane drugs for this type of cancer.
- Have not been treated with certain other cancer drugs like AR degraders or opevesostat.
- Must continue hormone therapy to keep testosterone levels low.
- Have tried a PARP inhibitor if suitable, or have been advised against it by a doctor, or have chosen not to take it.
- Have tried at least one androgen receptor pathway inhibitor (ARPi).
- Have cancer that can be measured by specific criteria, with or without visible tumors on scans.
- Be willing to provide a tumor sample for research during the screening phase.
- Have good organ function based on medical tests.
Exclusion Criteria
- Have had chemotherapy, radiation, or biological cancer treatment within 21 days before starting the study, or have not recovered from side effects of previous treatments.
- Have used a GSPT1 degrader and stopped due to side effects.
- Have had a stem cell transplant and not fully recovered.
- Have had a donor stem cell transplant in the last 6 months or have symptoms of graft-versus-host disease.
- Are using high doses of steroids regularly.
- Have active cancer in the brain or spinal cord, or cancer-related meningitis.
- Have a history of lung inflammation that needed steroid treatment.
- Have serious heart disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START Los Angeles | 90025 | Los Angeles | California |
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| Rocky Mountain Cancer Center | 80907 | Colorado Springs | Colorado |
| Kansas University Cancer Center | 66160 | Kansas City | Kansas |
| University of Maryland Greenebaum Cancer Center | 21201 | Baltimore | Maryland |
| Henry Ford | 48377 | Novi | Michigan |
| XCancer Omaha | 68130 | Omaha | Nebraska |
| START New Jersey | 08816 | East Brunswick | New Jersey |
| Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| Lancaster Urology | 17601 | Lancaster | Pennsylvania |
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