Study on JDQ443 Combination Therapy for Advanced Solid Tumors with KRAS G12C Mutation
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT05358249
This clinical trial is testing a new treatment, JDQ443, combined with other therapies for patients with advanced solid tumors that have a specific KRAS G12C mutation. The study aims to find the best dose and evaluate the safety and effectiveness of these combinations.
Patient Parameters
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Program Overview
This study is exploring a new treatment approach using JDQ443, combined with other selected therapies, for patients with advanced solid tumors that have the KRAS G12C mutation. The trial will first determine the safest and most effective dose of these combinations. If successful, the study will continue to further assess the safety and how well the treatment works against tumors.
Description
In this trial, JDQ443 is the main treatment and will be combined with other therapies to form different treatment groups. The study will start by testing different doses to find the safest and most effective one. If a combination is found to be safe, it may move to the next phase to further explore its safety and effectiveness in shrinking tumors.
Eligibility Criteria
Inclusion Criteria
- For dose escalation: Patients with advanced KRAS G12C mutant solid tumors who have already tried standard treatments or cannot receive them.
- For Phase II: Patients with advanced KRAS G12C mutant non-small cell lung cancer who have tried platinum-based chemotherapy and immune therapy, unless they were not eligible for these treatments.
- Patients with advanced KRAS G12C mutant colorectal cancer who have tried specific chemotherapy treatments, unless they were not eligible.
- All patients must be in good overall health with an ECOG performance status of 0 or 1.
- Patients must have a tumor that can be biopsied according to their hospital's guidelines.
Exclusion Criteria
- Tumors with other mutations that have approved treatments, except for KRAS G12C mutations.
- Patients who have previously been treated with a KRAS G12C inhibitor in certain groups in Phase II.
- Active brain tumors or cancer spread to the brain or spinal fluid.
- Significant heart disease or risk factors at the start of the study.
- Poor bone marrow, liver, or kidney function at the start of the study.
- Other specific criteria may apply as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| NYU School of Medicine | 10015 | New York | New York |
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