First-in-human, Phase 1/2, open-label, multicenter, dose-escalation and expansion study

Phase 1

Recruiting

• Conditions: MTAP-deleted Advanced or Metastatic Solid Tumors; MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502645-99-00
• Lead Sponsor: Tango Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

1.Age: =18 years-of-age at the time of signature of the main study ICF, 10.Written informed consent must be obtained according to local guidelines, 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

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to TNG462 or its excipients, 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, 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., Tener metástasis del SNC asociadas con síntomas neurológicos progresivos, Current active liver disease from any cause, Known to be HIV positive, unless all of the following criteria are met: a.CD4+ count =300/µL b.Undetectable viral load c.Receiving highly active antiretroviral therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified