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

Recruiting now · Phase 1/Phase 2

Conditions studied: Locally Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT05732831

Run by

Tango Therapeutics, Inc.

People needed

225

Starts

2023-05-26

Expected to finish

2026-09-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Currently participating in or has planned participation in a study of another investigational agent or device
• Impairment of GI function or disease that may significantly alter the absorption of oral TNG462
• Active prior or concurrent malignancy.
• Central nervous system metastases associated with progressive neurological symptoms
• Current active liver disease from any cause
• 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
• Clinically relevant cardiovascular disease
• A female patient who is pregnant or lactating
• 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

Where it is running

• Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
• Grand Valley Oncology — Grand Junction, Colorado, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• University Chicago Medicine — Chicago, Illinois, United States (enrolling)
• Carle Cancer Center — Urbana, Illinois, United States (enrolling)
• Midwestern Regional Medical Center, City of Hope Chicago — Zion, Illinois, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Cancer Center — Detroit, Michigan, United States (enrolling)
• New York University Langone Health — New York, New York, United States (enrolling)
• Sarah Cannon Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
• Next Oncology Virginia — Fairfax, Virginia, United States (enrolling)
• CHU de Brest — Brest, France (enrolling)
• Centre Berard Leon — Lyon, France (enrolling)
• Institut de Cancerologie de l'Ouest - Hôpital Saint Herblain - PPDS — Saint-Herblain, France (enrolling)
• Institute Gustav Roussy — Villejuif, France (enrolling)
• Vall d'Hebron Barcelona Hospital — Barcelona, Catalonia, Spain (enrolling)
• Hospital HM Nou Delfos — Barcelona, Spain (enrolling)
• ICO l'Hospitalet - Hospital Duran i Reynals — Barcelona, Spain (enrolling)
• Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
• Hospital de Sanchinarro — Madrid, Spain (enrolling)
• Hospital Universitario Virgen de la Victoria — Málaga, Spain (enrolling)

Full record on ClinicalTrials.gov

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