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TNG462 (full chemical name N-(6-AMINO-5-ETHYLPYRIDIN-3-YL)-2-((2R,5S)-5-METHYL-2-(2-(1-METHYLPIPERIDIN-4-YL)BENZO[D]THIAZOL-5-YL)PIPERIDIN-1-YL)-2-OXOACETAMIDE) is an investigational substance. It has not received a marketing authorisation and is being studied for the first time in humans. The available registry data do not state a drug class, other names, or trade names for TNG462.
The registry record for NCT05732831 does not describe the mechanism of action of TNG462. The trial focuses on tumors with an MTAP deletion, a genetic change in which the MTAP gene is missing. The study is designed to assess the antineoplastic activity of TNG462 in participants with MTAP-deleted advanced solid tumors, but the molecular target of TNG462 is not stated in the provided data.[1]
The trial studies TNG462 in one condition:
In the trial, TNG462 is given by oral use.[1] The registry record does not specify a pharmaceutical form such as a tablet or capsule. The combination arm also includes pembrolizumab, which is listed with an oral-use route in this record, and midazolam oromucosal solution (BUCCOLAM) is listed among the interventions.
There is one registered clinical trial for TNG462: a Phase 1/2, first-in-human, open-label, multicenter, dose-escalation and expansion study (NCT05732831). It plans to enroll 193 participants and is currently authorised.[1]
The study has two parts. Phase 1 aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2Ds) of TNG462 when given alone and in combination with pembrolizumab. Phase 2 aims to assess the antineoplastic activity of TNG462 in participants with MTAP-deleted advanced solid tumors, again as a single agent and in combination with pembrolizumab.[1]
Phase 1 measures the incidence of dose-limiting toxicities (DLTs) within the first 28 days of treatment with TNG462 alone and within the first 21 days of treatment with TNG462 plus pembrolizumab. Phase 2 measures the objective response rate (ORR), defined as complete response plus partial response, the duration of response (DOR), progression-free survival (PFS), and the clinical benefit rate (CBR) at 16 weeks, defined as complete response plus partial response plus stable disease.[1]
The study does not report results yet. The registry record provides the design and planned measurements but no efficacy or safety findings.
No side effect data are available from the provided sources. The trial is designed to measure dose-limiting toxicities during the first weeks of treatment, but no results have been reported in the registry record.[1]
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