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NCT04699188phase 1 2active not recruiting
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
344
Enrollment · actual
16
Countries · 38 sites
2027-01
Primary completion
5 mo ago
Record updated
Commercial relevance
Trial record references molecular eligibility required.
Molecular eligibility required
Biomarker requirement language
- Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies
- Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible
Change timeline
Signals from this trial
- New trial55/100Opportunity
New phase 1_2 trial NCT04699188 posted by Novartis Pharmaceuticals: "Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation".
Eligibility — raw, for validation
Inclusion Criteria: * Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies * ECOG Performance Status of 0 or 1 * At least one measurable lesion as defined by RECIST 1.1 * Prior treatment with a KRAS G12C inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion Exclusion Criteria: * Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations * Symptomatic brain metastases or known leptomeningeal disease. Patients with asymptomatic treated or untreated brain metastases may be eligible * Clinically significant cardiac disease or risk factors at screening * A medical condition that results in increased photosensitivity Other protocol-defined inclusion/exclusion criteria may apply.