QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
Purpose
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
Condition
- Advanced Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1a: QTX3544 monotherapy dose escalation |
QTX3544 will be administered at protocol defined dose based on cohort assignment |
|
|
Experimental Part 1b: QTX3544 dose escalation in combination with cetuximab |
QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
|
|
Experimental Part 2: QTX3544 monotherapy dose expansion |
QTX3544 will be administered at protocol defined dose based on cohort assignment |
|
|
Experimental Part 3: QTX3544 dose expansion in combination with cetuximab |
QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment |
|
Recruiting Locations
Sarah Cannon Research Institute
Denver 5419384, Colorado 5417618 80218
Denver 5419384, Colorado 5417618 80218
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06511
New Haven 4839366, Connecticut 4831725 06511
Florida Cancer Specialists & Research Institute
Sarasota 4172131, Florida 4155751 34232
Sarasota 4172131, Florida 4155751 34232
South Texas Accelerated Research Therapeutics, LLC Midwest
Grand Rapids 4994358, Michigan 5001836 49546
Grand Rapids 4994358, Michigan 5001836 49546
Duke Cancer Center
Durham 4464368, North Carolina 4482348 27705
Durham 4464368, North Carolina 4482348 27705
Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
South Texas Accelerated Research Therapeutics, LLC San Antonio
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
Huntsman Cancer Institute, University of Utah
Salt Lake City 5780993, Utah 5549030 84112
Salt Lake City 5780993, Utah 5549030 84112
South Texas Accelerated Research Therapeutics Mountain Region, LLC
West Valley City 5784607, Utah 5549030 84119
West Valley City 5784607, Utah 5549030 84119
More Details
- NCT ID
- NCT06715124
- Status
- Recruiting
- Sponsor
- Quanta Therapeutics