Study on BMS-986504 and Pemetrexed for Treating Metastatic Solid Tumors with MTAP Deletion

Sponsor: Northwestern University

Sponsor score: 0

ClinicalTrials ID:NCT07594626

Provider View

This clinical trial is testing a new treatment combining BMS-986504 and pemetrexed to see if it is safe and effective for patients with metastatic solid tumors that have a missing MTAP gene. The study aims to understand how well this combination works in stopping tumor growth.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with metastatic solid tumors that have a missing MTAP gene. The MTAP gene helps cells recycle important parts needed for growth. BMS-986504 is a drug that may stop tumor growth by blocking certain enzymes, while pemetrexed is a chemotherapy drug that stops cells from using folic acid to make DNA. The study will test if combining these two drugs is safe and effective in treating these types of tumors.

Description

The main goal of this study is to see if the combination of BMS-986504 and pemetrexed is safe and what side effects it might cause in patients with metastatic solid tumors missing the MTAP gene. Researchers also want to see how well the treatment works in shrinking tumors and how long the effects last.

Patients will take BMS-986504 by mouth once a day for 21 days and receive pemetrexed through an IV on the first day of each 21-day cycle. This cycle will repeat as long as the treatment is working and not causing unacceptable side effects. During the study, patients will have regular blood tests and CT scans to monitor their health and the treatment's effects.

After finishing the treatment, patients will have follow-up visits 30 days later and then every three months for up to a year to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic solid tumor with MTAP deletion, such as pancreatic, biliary, esophageal, or colon cancer.
  • The cancer must have progressed after at least one previous standard treatment.
  • Have at least one measurable tumor that can be tracked using CT scans.
  • Be 18 years or older.
  • Have a good overall health status, with an ECOG performance score of 0 or 1.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Be able to take folic acid, vitamin B12, and steroids as part of the treatment.
  • Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting the study.
  • Men must use condoms during sexual activity and refrain from donating sperm during and after the study.
  • Be able to stop taking certain medications like NSAIDs or aspirin around the time of pemetrexed administration.

Exclusion Criteria

  • Have previously received pemetrexed treatment, except for non-small cell lung cancer.
  • Have had treatment with PRMT5 or MAT2A inhibitors.
  • Have significant lung disease or have had chemotherapy or radiotherapy within 21 days before starting the study.
  • Have not recovered from side effects of previous cancer treatments.
  • Are taking other investigational drugs or have allergies to similar drugs as pemetrexed.
  • Have uncontrolled illnesses or conditions that could interfere with the study.
  • Have a history of heart disease or uncontrolled fluid buildup in the body.
  • Are unable to understand or comply with the study requirements.
  • Are pregnant or breastfeeding.
  • Have gastrointestinal conditions affecting drug absorption.
  • Have a prolonged QT interval on an ECG.
  • Are taking medications that affect heart rhythm or interact with the study drugs.
  • Are using herbal supplements or have certain viral infections without proper control.
  • Have received a live vaccine within 30 days before starting the study.
  • Have had recent surgery with general anesthesia within 7 days or local anesthesia within 3 days before starting the study.

Locations

FACILITYZIPCITYSTATE
Northwestern University60611ChicagoIllinois

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