Overview
Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.
Eligibility
Inclusion Criteria:
- Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D 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