Study on JDQ443 for Patients with Advanced Solid Tumors with KRAS G12C Mutation

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04699188

Provider View

This clinical trial is testing a new drug, JDQ443, alone and in combination with other treatments, to see if it is safe and effective for patients with advanced solid tumors that have a specific KRAS G12C mutation.

Patient Parameters

Program Overview

This study is in its early phases and aims to find out if the new drug JDQ443, either by itself or combined with other treatments (TNO155 and tislelizumab), is safe and can help treat advanced solid tumors with the KRAS G12C mutation. The study will first determine the safest dose of JDQ443 and then evaluate how well it works against tumors and its safety at that dose.

Eligibility Criteria

Inclusion Criteria

  • Adults with advanced solid tumors that have the KRAS G12C mutation and cannot be removed by surgery or have spread to other parts of the body.
  • Have tried standard treatments or cannot tolerate them or are not eligible for approved therapies.
  • Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one tumor that can be measured by scans.
  • May have had previous treatment with a KRAS G12C inhibitor for certain parts of the study.

Exclusion Criteria

  • Tumors with other mutations that have approved treatments, except for KRAS G12C mutations.
  • Have symptoms from brain metastases or known cancer spread to the brain's lining. Patients with brain metastases that are not causing symptoms may be eligible.
  • Have significant heart disease or risk factors at the time of screening.
  • Have a medical condition that makes the skin more sensitive to sunlight.
  • Other specific criteria may apply as defined by the study protocol.

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