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Terminated NCT05358249

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

Conditions: KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, Nonsmall Cell Lung Cancer, Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms, Colorectal Tumors, Neoplasms, Colorectal

Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 74
Sponsor: Novartis Pharmaceuticals

Location: Massachusetts General Hospital Boston Massachusetts

Summary

This was 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.

Eligibility 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 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05358249). StuddyBuddy aggregates publicly available trial information.