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.

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NCT05732831

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Tango Therapeutics, Inc.
~225 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:TNG462Pembrolizumab

At a glance

Recruiting sites
25 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 Maximum Tolerated Dose
Measured over 28 days and 21 days
+2 more outcomes measured
Locally Advanced Solid Tumor
26 sites across 14 states
Spain6
France4
Illinois3
Florida2
Massachusetts2
California1
Colorado1
Michigan1
  • Maxim Pimpkin, MD · STUDY_DIRECTOR · Tango Therapeutics, Inc.

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  • 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