NCT06227377PHASE1Recruiting
QTX3034 in Patients With KRAS G12D Mutation
Quanta Therapeutics
Start Date
2/5/2024
Completion Date
4/1/2027
Summary
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Eligibility Criteria
Age Range: 18 years to No maximum
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 protocol-defined Inclusion/Exclusion Criteria may apply
Interventions
DRUG
QTX3034
COMBINATION_PRODUCT
Cetuximab
Conditions
Solid Tumors
Locations
UCLA Hematology/Oncology
Los Angeles, California 90095
United States
Sarah Cannon Research Institute (SCRI)
Denver, Colorado 80218
United States
Yale Cancer Center
New Haven, Connecticut 06511
United States
Florida Cancer Specialists
Sarasota, Florida 34232
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
NYU Langone Health
New York, New York 10016
United States
Montefiore Medical Center
The Bronx, New York 10461
United States
Duke University
Durham, North Carolina 27710
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
SCRI- Nashville
Nashville, Tennessee 37203
United States
MD Anderson
Houston, Texas 77030
United States
START San Antonio, LLC
San Antonio, Texas 78229
United States
University of Utah, Huntsman Cancer Center
Salt Lake City, Utah 84112
United States
NEXT Oncology Virginia
Fairfax, Virginia 22031
United States