Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

• Status: Not yet recruiting
• Trial end date: 2025-05-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cetuximab; Trametinib

Criteria

Inclusion Criteria:

Dose Escalation:

• 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:

• Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received one platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy

• 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:

• ECOG performance status of 0 or 1.

• 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:

• Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations

• Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II.

• Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease

• Clinically significant cardiac disease or risk factors at screening

• Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply