Study on Alrizomadlin (APG-115) for Patients with BAP1 Cancer Syndrome and Early-Stage Mesothelioma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06654050

Provider View

This clinical trial is testing a new drug, APG-115, for people with BAP1 Cancer Syndrome and early-stage mesothelioma. The study aims to see if the drug can help stabilize or improve the condition in patients who have not yet needed standard treatments.

Patient Parameters

Program Overview

Mesothelioma is a rare cancer often linked to asbestos exposure, but people with BAP1 Cancer Syndrome can develop it without such exposure. This study is exploring the use of a new drug, APG-115, in patients with early-stage mesothelioma who have a genetic mutation called BAP1. The goal is to see if the drug can help control the disease before it requires standard treatments like surgery or chemotherapy.

Description

This study involves testing a new drug, APG-115, in patients with BAP1 Cancer Syndrome who have early-stage mesothelioma. Mesothelioma is a type of cancer that affects the lining of the lungs and other organs. People with a genetic mutation in the BAP1 gene are more likely to develop this cancer, even without exposure to asbestos.

Participants in the study will take APG-115 capsules at home every other day for 13 days in a 21-day cycle. The study will last for up to 16 cycles, with regular check-ins and tests to monitor health and response to the treatment. Participants will have blood tests and imaging scans to track the progress of the disease.

The study aims to determine if APG-115 can help stabilize or improve the condition in patients with early-stage mesothelioma, potentially delaying the need for more aggressive treatments. Participants will also be involved in additional research studies to help understand the effects of the drug on the body.

Eligibility Criteria

Inclusion Criteria

  • Must have a genetic mutation in the BAP1 gene.
  • Diagnosed with early-stage mesothelioma that does not yet require standard treatments like surgery or chemotherapy.
  • Aged 18 years or older.
  • Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Willing to undergo minimally invasive procedures to assess the disease and response to treatment.
  • Must have adequate heart, kidney, liver, and blood function as determined by specific tests.
  • Must agree to use effective contraception during the study and for three months after the last dose of APG-115.
  • Must be willing to stop breastfeeding during the study and for four weeks after the last dose of the study drug.
  • Must understand the study and agree to sign a written informed consent document.

Exclusion Criteria

  • Have any cancers that require standard treatments like surgery or chemotherapy.
  • Have significant heart or blood vessel diseases, such as recent stroke or heart attack.
  • Have unstable heart conditions or serious heart rhythm problems.
  • Have a prolonged QT interval on an ECG (QTcF greater than 470 milliseconds).
  • Are on blood thinners or certain medications that affect the liver enzyme CYP3A4/3A5.
  • Have active hepatitis A, B, or C infections.
  • Are HIV positive.
  • Have active infections that require treatment.
  • Are taking immunosuppressive medications, except for certain non-systemic steroids.
  • Are pregnant or have a positive pregnancy test.
  • Have any uncontrolled illnesses or unstable medical conditions.

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