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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Is currently participating in or has planned concurrent participation in a study of another investigational agent or device.
. Has impairment of GI function or disease that may significantly alter the absorption of the oral medications
. Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms