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QTX3034 in Patients With KRAS G12D Mutation
RecruitingPhase 1
A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
What is being tested
- QTX3034 (drug)
- Cetuximab (combination product)
Sponsor: Quanta Therapeutics · Participants: 250 · Started: Feb 5, 2024
Contact the study team
- Quanta Therapeutics Clinical Trials · Phone: 415-599-3892
Official record on ClinicalTrials.gov — NCT06227377
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.