Phase I
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
- Study HIC#:2000039675
- Last Updated:08/29/2025
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
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
