QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

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