Study on MRTX0902 for Treating Solid Tumors with KRAS MAPK Pathway Mutations

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05578092

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, MRTX0902, alone and in combination with another drug, adagrasib, for patients with advanced solid tumors that have specific genetic mutations.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective MRTX0902 is, both on its own and when combined with adagrasib, in treating advanced solid tumors with mutations in the KRAS-MAPK pathway. It will start by testing different doses of MRTX0902 to find the best one. Once the safety and how the body processes the drug are understood, the study will test the combination of MRTX0902 and adagrasib. The study will also look at how food affects the drug when taken with adagrasib. If successful, the study will expand to include more patients to gather more information and determine the best treatment plan for future studies.

Description

This clinical trial is the first to test MRTX0902 in humans. It will begin by exploring different doses and schedules of MRTX0902 to find the safest and most effective way to use it. Once enough information is gathered about using MRTX0902 alone, the study will start testing it in combination with another drug, adagrasib. This part of the study will also look at how food might affect the drug's effectiveness when taken with adagrasib. If promising treatment plans are found, the study will expand to include more patients to ensure enough safety and effectiveness data is collected. In the second phase, the study will focus on specific groups of patients based on their cancer type and characteristics to evaluate how well the combination of MRTX0902 and adagrasib works.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of a solid tumor with specific genetic mutations, such as KRAS mutations or others, as identified by approved tests.
  • Have cancer that cannot be surgically removed or has spread to other parts of the body.
  • No available treatment options with the intent to cure, or standard treatments are not available or declined by the patient.
  • Have tumors that can be measured or evaluated using standard criteria.
  • Have a tumor that can be biopsied for study purposes, unless it is unsafe or not possible.
  • Be in good overall health with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ function as determined by medical tests.

Exclusion Criteria

  • Have active cancer that has spread to the brain or the membranes covering the brain and spinal cord.
  • Have previously been treated with a KRAS G12C inhibitor (for certain parts of the study).
  • Have had significant coughing up of blood or bleeding within four weeks before starting the study treatment.
  • Have had major surgery within four weeks before starting the study treatment.
  • Have a history of lung inflammation or lung disease.
  • Need ongoing medication that affects how the body processes drugs, such as certain enzyme inhibitors or inducers.
  • Have heart problems.
  • Have a history of intestinal diseases or conditions that affect digestion or the ability to swallow pills.

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