QTX3034 in Patients With KRAS G12D Mutation

A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.

Inclusion Criteria:

• Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation 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 1 prior systemic therapy
• Evaluable or Measurable disease per RECIST 1.1.
• Parts 2 and 3: Measurable disease per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate organ function

Exclusion Criteria:

• Prior treatment with a KRAS inhibitor
• Active brain metastases or carcinomatous meningitis
• History of other malignancy within 2 years
• Significant cardiovascular disease
• Disease or disorder that may pose a risk to patient's safety

Other protocol-defined Inclusion/Exclusion Criteria may apply