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QTX3034 in Patients With KRAS G12D Mutation
Trial Status: active
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
Additional locations may be listed on ClinicalTrials.gov for NCT06227377.