Study on Avutometinib and Defactinib for Diffuse Stomach Cancer

Sponsor: Ryan H. Moy, MD, PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06487221

Provider View

This clinical trial is testing a combination of two drugs, avutometinib and defactinib, to see if they can help people with diffuse-type stomach cancer live longer, reduce tumor size, and ensure safety.

Patient Parameters

Program Overview

The study aims to find out if using the drugs avutometinib and defactinib together can help people with diffuse-type stomach cancer live longer without their cancer growing or spreading. These drugs work by blocking certain proteins that help cancer cells grow. Participants in this study have stomach cancer that has spread or cannot be removed by surgery, and have already tried chemotherapy without success.

Description

Stomach cancer can be classified into different types based on how the cells look under a microscope. This study focuses on diffuse-type stomach cancer, which can be more challenging to treat. Participants in this study have stomach cancer that has spread to other parts of the body or cannot be surgically removed. They may also have specific gene changes linked to diffuse-type stomach cancer, such as mutations in the CDH1 or RHOA genes.

The study is testing two oral drugs: defactinib, which blocks a protein called FAK that helps cancer grow, and avutometinib, which blocks two proteins in a cancer cell pathway known as the MAP kinase pathway. The goal is to see if this combination can help patients live longer without their cancer getting worse.

Participants must have already received chemotherapy, including platinum and fluoropyrimidine, and their cancer must be growing despite this treatment. The study will monitor how long participants live without their cancer growing and assess the safety of the drug combination.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with diffuse-type or mixed-type stomach cancer, or have specific gene mutations (CDH1 or RHOA) linked to this cancer type.
  • Previously treated with at least one line of therapy for cancer that cannot be removed or has spread, including platinum and fluoropyrimidine.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Aged 18 years or older.
  • Have adequate organ function based on specific blood tests.
  • Cancer that can be measured by scans or other methods.
  • Tumor that can be biopsied, including fluid buildup in the abdomen that can be sampled.
  • Normal heart rhythm as measured by an ECG.
  • Recovery from previous treatment side effects to a manageable level.
  • Agree to use effective contraception during the study and for a period after.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Recent treatment with other cancer therapies or investigational drugs.
  • History of other cancers within the last two years, except for certain low-risk types.
  • Recent major surgery or radiation therapy.
  • Taking warfarin, unless switched to another blood thinner.
  • Previous treatment with drugs that specifically target FAK, MEK, or KRAS.
  • Use of certain medications or supplements that interact with the study drugs.
  • Active brain metastases requiring treatment.
  • Active infections like hepatitis B, C, or HIV.
  • Skin disorders needing systemic treatment in the past year.
  • History of muscle breakdown (rhabdomyolysis).
  • Eye disorders that could increase risk during the study.
  • Serious heart or lung conditions.
  • Difficulty swallowing pills.
  • Allergies to ingredients in the study drugs.
  • Pregnant or breastfeeding women.
  • Any other medical condition that could increase risk during the study.

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