Testing the Effect of M1774 on Hard-to-Treat SPOP-Mutant Prostate Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT05828082

Provider View

This clinical trial is exploring how well a new drug, M1774, works in treating prostate cancer that is difficult to treat and has a specific genetic mutation. The study aims to see if M1774 can shrink or stabilize these tumors by blocking certain enzymes needed for cancer cell growth.

Patient Parameters

Program Overview

This phase II study is testing a new drug called M1774 to see if it can help treat prostate cancer that doesn't respond to other treatments and has a mutation in the SPOP gene. M1774 may work by stopping the growth of cancer cells. The goal is to find out if M1774 can shrink or stabilize these hard-to-treat tumors.

Description

The main goal of this study is to see how well the drug M1774, also known as tuvusertib, works in treating prostate cancer that is very resistant to other treatments. Researchers will also look at how long patients live and how long they stay without the cancer getting worse while taking M1774. They will monitor any side effects that occur during the treatment.

Patients will take M1774 by mouth every day for 14 days, with treatment cycles repeating every 21 days as long as the cancer does not progress or cause unacceptable side effects. Throughout the study, patients will have various tests, including biopsies, MRI, CT, PET scans, and blood tests.

After finishing the study treatment, patients will have follow-up visits every 6 months for 2 years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Have prostate cancer with SPOP mutations, confirmed by specific genetic tests.
  • Have at least one tumor that can be measured by scans or physical exam.
  • Have low testosterone levels after hormone therapy or surgery.
  • Have previously been treated with certain anti-cancer drugs.
  • Be 18 years or older.
  • Be in relatively good health, able to perform daily activities with some limitations.
  • Have adequate blood cell counts and organ function based on specific tests.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with hepatitis B or C can participate if the virus is under control or cured.
  • Patients with treated brain metastases can participate if there is no sign of progression.
  • Patients with other cancers can participate if it does not interfere with this study.
  • Patients with heart disease must have a certain level of heart function.
  • Men must agree to use contraception during and after the study to prevent pregnancy in partners.
  • Must understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Have not fully recovered from side effects of previous cancer treatments, except hair loss.
  • Are taking other experimental drugs.
  • Have uncontrolled health issues.
  • Cannot stop taking certain stomach acid medications or other specific drugs.
  • Have a heart condition with a specific abnormal heart rhythm.

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