Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Pa… (NCT06922591) | Clinical Trial Compass
RecruitingPhase 1/2
Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
United States183 participantsStarted 2025-05-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Pathologically documented metastatic PDAC or locally advanced, recurrent or metastatic NSCLC
✓. Has received prior standard therapy
✓. Arms A and B only: Must not have received prior RAS-targeted therapy
✓. Has evidence of measurable disease based on RECIST v1.1.
Exclusion criteria
✕. 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.
✕. Has an active infection requiring systemic therapy.