TNG462 for MTAP-deleted Solid Tumors
This study is testing a new oral drug called TNG462, alone and with pembrolizumab (an anti PD-1 antibody, a type of immunotherapy), for people with locally advanced, metastatic, or unresectable solid tumors that have an MTAP deletion. This is a "first-in-human" study, meaning it's the first time TNG462 is being given to people. The main goals are to find a safe dose and see how well TNG462 works against these tumors. You must be at least 18 years old, have a good performance status (meaning you can perform daily activities), and have tried standard treatments if available. The study plans to enroll up to 225 participants. The current recruitment status is unclear.
- Study design
- This is a Phase 1/2, multi-center, open-label study. It involves a dose-escalation part (Phase 1) and then an expansion part (Phase 2) for specific tumor types.
- What's involved
- Participants will receive TNG462 orally and/or pembrolizumab intravenously. If you tolerate the drug, you may continue treatment until your disease progresses.
- Compensation
- Not stated in the trial record.
- Follow-up
- Anti-neoplastic activity (how well the treatment works against cancer) will be measured at 16 and 18 weeks. Maximum Tolerated Dose and Dosing Schedule will be measured at 21 and 28 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
At a glance
Conditions
Where it's being run
26 sites across 14 statesStudy leadership
- Maxim Pimpkin, MD · STUDY_DIRECTOR · Tango Therapeutics, Inc.
Who to contact
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What this trial measures
- Phase 1 Maximum Tolerated Dose28 days and 21 days
To determine the maximum tolerated dose (MTD) of TNG462 when administered as a single agent and in combination with pembrolizumab
- Phase 1 Dosing Schedule28 days
To determine the dosing schedule of TNG462
- Phase 2 Anti-neoplastic Activity16 weeks and 18 weeks
To assess anti-neoplastic activity of TNG462 administered single agent and in combination with pembrolizumab in patients with MTAP-deleted advanced solid tumors by RECIST v1.1, iRECIST or mRECIST v1.1