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.
Is ≥18 years of age at the time of signature of the main study ICF.
Has an ECOG PS of 0 or 1.
Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene
Arms A and B only: Has a tumor with a RAS mutation
Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor
Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805
Known allergy, hypersensitivity or intolerance to TNG462 (all arms), RMC-6236 Arm A), RMC-9805 (Arm B), mFOLFIRINOX (Arm C), gemcitabine/nab-paclitaxel (Arm D) or their excipients
Has uncontrolled intercurrent illness that will limit compliance with the study requirements.
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Treatment groupsSee each treatment group below.
Tango Therapeutics, Inc.
Lead sponsor
Revolution Medicines, Inc.
Collaborator