Study on MRTX1133 for Patients with Advanced Solid Tumors with a KRAS G12D Mutation

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05737706

Provider View

This clinical trial is testing a new drug, MRTX1133, to see if it is safe and effective for treating advanced solid tumors that have a specific genetic mutation called KRAS G12D.

Patient Parameters

Program Overview

This study is in its early stages and aims to find the best dose and schedule for the new drug MRTX1133 in patients with advanced solid tumors that have a KRAS G12D mutation. The trial will start by testing different doses to ensure safety and gather information on how the drug behaves in the body. If successful, the study will expand to include more patients to further evaluate the drug's effectiveness and safety. In the later phase, the study will look at how well the drug works in different groups of patients based on their cancer type and other characteristics.

Description

This is the first time MRTX1133 is being tested in humans. The trial will begin by exploring different doses and schedules of the drug to find the most effective and safe way to use it. As the study progresses, more patients will be included to gather enough information about the drug's safety and how it works in the body. The goal is to identify the best treatment plan for future studies. In the second phase, the study will focus on how well the drug works in different groups of patients, based on their specific type of cancer and other factors. This will help determine the drug's effectiveness and potential benefits for patients with advanced solid tumors that have the KRAS G12D mutation.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of a solid tumor with a KRAS G12D mutation, either in tumor tissue or blood tests.
  • Have cancer that cannot be removed by surgery or has spread to other parts of the body.
  • Have already tried standard treatments suitable for their type and stage of cancer; for some groups, this includes first-line treatment for pancreatic cancer.
  • Have tumors that can be measured or evaluated using standard criteria:
    • In the initial phase, patients must have measurable or evaluable disease.
    • In later phases, patients must have measurable disease.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function.
  • Be 18 years or older.

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 G12D inhibitor (for certain phases of the study).
  • Have had significant coughing up of blood or bleeding within four weeks before starting the study treatment.
  • Have a history of intestinal diseases, inflammatory bowel disease, major stomach surgery, or other conditions that could affect the absorption of the study drug or the ability to swallow pills.
  • Have a history of malignant small bowel obstruction.
  • Have heart problems.

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