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Testing TNG462 for patients with specific solid tumors

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

PHASE1; PHASE2 · Tango Therapeutics, Inc. · NCT05732831

This study is testing a new drug called TNG462 to see if it can safely help people with advanced solid tumors that have a specific genetic change.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment225 (estimated)
Ages18 Years and up
SexAll
SponsorTango Therapeutics, Inc. (industry)
Drugs / interventionspembrolizumab
Locations26 sites (Palo Alto, California and 25 other locations)
Trial IDNCT05732831 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of TNG462, a selective PRMT5 inhibitor, in patients with advanced or metastatic solid tumors that have a confirmed homozygous MTAP deletion. The study consists of two phases: an initial dose escalation phase followed by a dose expansion phase targeting specific tumor types. Participants may continue treatment with TNG462 until disease progression if they tolerate the drug well. The trial aims to enroll up to 225 participants across multiple centers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that have a confirmed homozygous MTAP deletion.

Not a fit: Patients with solid tumors that do not have an MTAP deletion or those with uncontrolled intercurrent illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with MTAP-deleted solid tumors.

How similar studies have performed: While this approach is novel in targeting MTAP-deleted tumors, similar studies with targeted therapies have shown promise in other cancer types.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age: ≥18 years-of-age at the time of signature of the main study ICF
2. Performance status: ECOG Performance Score of 0 to 1
3. Confirmed histologic or cytologic diagnosis of a locally advanced, metastatic, and/or unresectable solid tumor
4. Prior standard therapy, as available
5. 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.
6. Adequate organ function/reserve per local labs
7. Adequate liver function per local labs
8. Adequate renal function per local labs
9. Negative serum pregnancy test result at screening
10. Written informed consent must be obtained according to local guidelines

Exclusion Criteria:

1. Known allergies, hypersensitivity, or intolerance to TNG462, or its excipients or to pembrolizumab in the combination treatment arms
2. Uncontrolled intercurrent illness that will limit compliance with the study requirements
3. Active infection requiring systemic therapy
4. Currently participating in or has planned participation in a study of another investigational agent or device
5. Impairment of GI function or disease that may significantly alter the absorption of oral TNG462
6. Active prior or concurrent malignancy.
7. Central nervous system metastases associated with progressive neurological symptoms
8. Current active liver disease from any cause
9. Known to be HIV positive, unless all of the following criteria are met:

   1. CD4+ count ≥300/μL
   2. Undetectable viral load
   3. Receiving highly active antiretroviral therapy
10. Clinically relevant cardiovascular disease
11. A female patient who is pregnant or lactating
12. Patient is unwilling or unable to comply with the scheduled visits, drug administration plan, laboratory tests, biopsy, or other study procedures and study restrictions
13. 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

Where this trial is running

Palo Alto, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Locally Advanced Solid Tumor, MTAP deletion, PRMT5, cholangiocarcinoma, NSCLC, mesothelioma, MPNST, Tango

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.