A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Summary
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Arms & interventions
- DrugQTX3034
QTX3034 will be administered at protocol defined dose
- Combination ProductCetuximab
Cetuximab will be administered at protocol defined dose.
Outcome measures
Primary
Number of participants with Dose Limiting Toxicities (DLTs)
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol
Time frame: up to 21 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab
Time frame: up to 2 years
Secondary
QTX3034 pharmacokinetic parameters in plasma
Time frame: up to 2 years
Objective response rate (ORR)
Time frame: up to 2 years
Duration of response (DOR)
Time frame: up to 2 years
Eligibility criteria
Study locations (14)
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
Montefiore Medical Center
The Bronx, New York, 10461
Duke University
Durham, North Carolina, 27710
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
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