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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
183
MTA cooperative PRMT5 inhibitor
RAS(ON) G12D selective covalent inhibitor
RAS(ON) multi-selective inhibitor
Chemotherapy
Chemotherapy
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
RECRUITINGSarah Cannon Research Institute Denver
Denver, Colorado, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
RECRUITINGUniversity of Indiana
Indianapolis, Indiana, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMayo Clinic Cancer Center
Rochester, Minnesota, United States
RECRUITINGNebraska Cancer Specialists
Omaha, Nebraska, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITING...and 2 more locations
Phase 1: Maximum Tolerated Dose
To determine the MTD and RD(s) of TNG462 in combination with RMC-6236 or RMC-9805
Time frame: 21 days
Phase 1: Maximum Tolerated Dose
To determine the MTD and RD(s) of TNG462 in combination with mFOLFIRINOX or gemcitabine/nab-paclitaxel
Time frame: 28 days
Phase 2: Combination Anti-neoplastic Activity
To assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel using RECIST 1.1
Time frame: 12 weeks
Phase 1: Combination Anti-neoplastic Activity
To assess preliminary evidence of antineoplastic activity of TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX, or gemcitabine/nab paclitaxel using RECIST 1.1
Time frame: 12 weeks
Phase 1 and 2: Tmax of TNG462 and in Combination
To characterize the Tmax of TNG462 in combination with RMC-6236 or RMC-9805
Time frame: 21 days
Phase 1 and 2: Tmax of TNG462 and in Combination
To characterize the Tmax of TNG462 in combination with mFOLFIRINOX, or gemcitabine/nab-paclitaxel
Time frame: 28 days
Phase 1 and 2: Cmax of TNG462 and in Combination
To characterize the Cmax of TNG462 in combination with RMC-6236 or RMC-9805
Time frame: 21 days
Phase 1 and 2: Cmax of TNG462 and in Combination
To characterize the Cmax of TNG462 in combination with mFOLFIRINOX, or gemcitabine/nab-paclitaxel
Time frame: 28 days
Phase 1 and 2: AUC of TNG462 and in Combination
To characterize the AUC of TNG462 and in combination with RMC-6236 or RMC-9805
Time frame: 21 days
Phase 1 and 2: AUC of TNG462 and in Combination
To characterize the AUC of TNG462 in combination with mFOLFIRINOX, or gemcitabine/nab-paclitaxel
Time frame: 28 days
Phase 1 and 2 Adverse Event Profile
To determine the safety and tolerability of TNG462 in combination with RMC-6236 or RMC-9805
Time frame: 21 days
Phase 1 and 2 Adverse Event Profile
To determine the safety and tolerability of TNG462 in combination with mFOLFIRINOX or gemcitabine nab-paclitaxel
Time frame: 28 days
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