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

Active Not RecruitingPhase 1, Phase 2

Sponsor: Novartis Pharmaceuticals

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

Interventions: JDQ443, trametinib, Ribociclib, cetuximab

Countries: United States, Belgium, France, Germany, Italy, Singapore, South Korea, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (13)

Boston, Massachusetts, United States
Boston, Massachusetts, United States
New York, New York, United States
Leuven, Belgium
Bordeaux, France
Lyon, France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Milan, MI, Italy
Singapore, Singapore
Seoul, South Korea
Barcelona, Spain
Madrid, Spain
Madrid, Spain