Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
About the study
Who can take part
INCLUSION 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
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
Study Locations
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How to Apply
Study Details
Contition
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
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
346
Est. Completion Date
Jun 16, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Novartis
ClinicalTrials.gov NCT Identifier
NCT05358249
Study Number
CJDQ443E12101
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