Study on LY3537982 for Cancer Patients with a Specific Genetic Mutation (KRAS G12C)

Sponsor: Eli Lilly and Company

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04956640

Provider View

This clinical trial is testing a new drug, LY3537982, to see if it is safe and effective for cancer patients with a specific genetic mutation called KRAS G12C. The study is for patients who have already tried standard treatments or couldn't tolerate them, except for certain groups who haven't had cancer treatment yet. The study will last up to 4 years.

Patient Parameters

Program Overview

The study aims to find out if LY3537982 is safe and works well in patients with solid tumors that have a KRAS G12C mutation. It will be conducted in four parts, starting with finding the right dose and then testing its effectiveness. The mutation will be identified through standard testing methods.

Description

This is an open-label study, meaning both the researchers and participants know what treatment is being given. It will take place in multiple centers and is divided into four parts: Phase 1a to find the right dose, Phase 1b to expand and optimize the dose, and Phase 2 to test its effectiveness. The study will include patients with KRAS G12C-mutant solid tumors, and the mutation will be identified through standard testing methods.

Eligibility Criteria

Inclusion Criteria

  • Have cancer that can be measured using standard criteria.
  • Have a KRAS G12C mutation in tumor tissue or blood.
  • Have a confirmed diagnosis of advanced or metastatic cancer and meet specific criteria for the study group.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Have good organ function.
  • Have stopped all previous cancer treatments and recovered from any significant side effects.
  • Be able to swallow pills.
  • Agree to use contraception if applicable.
  • For some parts of the study, have specific types of lung cancer that haven't been treated in the advanced stage, or have received certain treatments in the past.
  • For one part of the study, have received at least one prior treatment with specific chemotherapy drugs for advanced colorectal cancer.

Exclusion Criteria

  • Have cancer that can be treated with local therapy aimed at curing it.
  • Have an active or untreated infection.
  • Have a serious medical condition that would prevent participation in the study.
  • Have a serious heart condition.
  • Have another active cancer or have been treated for another cancer within the last 3 years.
  • For some parts of the study, have untreated active brain metastases, unless they are stable and not requiring steroids.
  • Have previously been treated with a KRAS G12C inhibitor, except in certain cases.
  • For some parts of the study, have had serious side effects from prior immunotherapy, have an active autoimmune disease needing treatment in the last 2 years, or have received a live vaccine recently.
  • Be pregnant, breastfeeding, or planning to have children during the study and for 180 days after the last dose.
  • Have a known allergy to any of the study treatments.

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