QTX3034 in Patients With KRAS G12D Mutation
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
| Condition(s) | Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab. |
| Who can participate | 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 p |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Quanta Therapeutics |
| Locations | Los Angeles, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Sarasota, Florida, United States; Tampa, Florida, United States; New York, New York, United States (+8 more sites) |
| Start date | 2024-02-05 |
| NCT ID | NCT06227377 |
| Official listing | https://clinicaltrials.gov/study/NCT06227377 |