About the study

This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

Dose Escalation:

1. Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy. Phase II:
2. Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
3. Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy. All patients:
4. ECOG performance status of 0 or 1.
5. Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines.

Exclusion criteria

1. Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
2. Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II.
3. Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease
4. Clinically significant cardiac disease or risk factors at screening
5. Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.