QTX3034 in Patients With KRAS G12D Mutation
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Quanta Therapeutics
- Study ID
- NCT06227377
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- QTX3034 — DRUGQTX3034 will be administered at protocol defined dose
- Cetuximab — COMBINATION_PRODUCTCetuximab will be administered at protocol defined dose.
Study Details
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Key Dates
- Start date
- Feb 5, 2024
- Status verified
- Apr 2026
- Primary completion
- Apr 1, 2027
- Completion
- Apr 1, 2027
Study Design
- Enrollment
- 250 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1a: QTX3034 monotherapy dose-escalationQTX3034 will be administered at protocol defined dose based on cohort assignment
- Experimental: Part 1b: QTX3034 combination with cetuximab dose-escalationQTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
- Experimental: Part 2: QTX3034 monotherapy dose-expansionQTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
- Experimental: Part 3: QTX3034 combination with cetuximab dose-expansionQTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Primary Outcome Measure
Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: up to 21 days ]
Central Contacts
- Quanta Therapeutics Clinical Trials415-599-3892
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | |
| Sarah Cannon Research Institute (SCRI) | Denver | Colorado | 80218 | |
| Yale Cancer Center | New Haven | Connecticut | 06511 | |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | |
| Moffitt Cancer Center | Tampa | Florida | 33612 | |
| NYU Langone Health | New York | New York | 10016 | DL_Phase1Screening |
| Montefiore Medical Center | The Bronx | New York | 10461 | |
| Duke University | Durham | North Carolina | 27710 | |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | Lana Seibert |
| SCRI- Nashville | Nashville | Tennessee | 37203 | |
| MD Anderson | Houston | Texas | 77030 | |
| START San Antonio, LLC | San Antonio | Texas | 78229 | |
| University of Utah, Huntsman Cancer Center | Salt Lake City | Utah | 84112 | |
| NEXT Oncology Virginia | Fairfax | Virginia | 22031 |
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