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QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
Trial Status: active
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544
as a single agent or in combination with cetuximab.
Inclusion Criteria
Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
Part 1: Advanced solid tumors with at least one prior systemic therapy.
Evaluable and measurable disease per RECIST v1.1.
Part 2 and 3: Measurable disease per RECIST v1.1.
Exclusion Criteria
Active brain metastasis or carcinomatous meningitis
Significant cardiovascular disease
Active infection requiring intravenous (IV) antibiotics
Prior treatment with a KRAS inhibitor Other protocol-defined Inclusion/Exclusion Criteria may apply
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06715124.
