A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Quanta Therapeutics
Summary
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * A…
Interventions
- DrugQTX3034
QTX3034 will be administered at protocol defined dose
- Combination ProductCetuximab
Cetuximab will be administered at protocol defined dose.
Locations (14)
- UCLA Hematology/OncologyLos Angeles, California
- Sarah Cannon Research Institute (SCRI)Denver, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- Florida Cancer SpecialistsSarasota, Florida
- Moffitt Cancer CenterTampa, Florida
- NYU Langone HealthNew York, New York