RecruitingLocally Advanced Solid Tumor

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

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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.

Sponsor: Tango Therapeutics, Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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