Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
Start Date
5/31/2025
Completion Date
12/1/2027
Summary
TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.
Detailed Description
TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. For the RAS inhibitor arms, the study will be conducted in patients with MTAP loss and RAS mutant metastatic pancreatic adenocarcinoma (PDAC) or locally advanced or metastatic non-small cell lung cancer (NSCLC). For the chemotherapy specific arms, the study will be conducted in patients with MTAP loss locally advanced or metastatic PDAC. The entire study (all arms) will be conducted in 2 parts: Phase 1 (dose escalation) and Phase 2 (dose expansion). Individual Arms in the dose expansion phase may open once the MTD and/or RD(s) has been determined for the corresponding combination in the dose escalation phase of the study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
TNG462
RMC-9805
RMC-6236
mFOLFIRINOX
gemcitabine/nab-paclitaxel
Conditions
Locations
Mayo Clinic Scottsdale
Scottsdale, Arizona 85259-5452
United States
Sarah Cannon Research Institute Denver
Denver, Colorado 80218
United States
Georgetown University Medical Center
Washington D.C., District of Columbia 20007
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611-2908
United States
University of Indiana
Indianapolis, Indiana 46202
United States
University of Iowa Health Care
Iowa City, Iowa 52242
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02115
United States
Mayo Clinic Cancer Center
Rochester, Minnesota 55905-0001
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68124
United States
NYU Langone Health
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 11065
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599-7305
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Dallas
Irving, Texas 74039
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
United States
NEXT Oncology
Fairfax, Virginia 22031
United States