Tests TNG462 in adults with advanced solid tumors lacking MTAP

Trial details

Who runs it

Tango Therapeutics, Inc.

Trial code

NCT05732831

Record updated

8 September 2026

Original description

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.Read full original descriptionShow less

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Inclusion: Age: ≥18 years-of-age at the time of signature of the main study ICF; Performance status: ECOG Performance Score of 0 to 1; Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor; Prior standard therapy, as available; Documented bi-allelic (homozygous) deletion of MTAP in a tumor detected by next- generation sequencing or absence of MTAP protein in a tumor detected by IHC; Adequate organ function/reserve per local labs; Adequate liver function per local labs; Adequate renal function per local labs; Negative serum pregnancy test result at screening; Written informed consent must be obtained according to local guidelines.

Exclusion: Currently participating in or has planned participation in a study of another investigational agent or device; Active prior or concurrent malignancy; Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms; Uncontrolled intercurrent illness that will limit compliance with the study requirements; Active infection requiring systemic therapy; Impairment of GI function or disease that may significantly alter the absorption of oral TNG462; Current active liver disease from any cause; Clinically relevant cardiovascular disease; Known to be HIV positive, unless all of the following criteria are met:; CD4+ count ≥300/μL; Undetectable viral load; Receiving highly active antiretroviral therapy; Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions; Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, may affect the safety of the patient or impair the assessment of study results; Central nervous system metastases associated with progressive neurological symptoms; A female patient who is pregnant or lactating.

ClinicalTrials.gov NCT05732831