Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

Sponsor: Tango Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05887492

Patient View

This Phase 1/2 open-label study evaluates the safety, tolerability, and pharmacokinetics of oral TNG260 with pembrolizumab in adults with STK11 mutated solid tumors. Participants must have measurable disease, adequate organ function, and no active infections. Exclusions include allergies to study drugs and active liver disease.

Patient Parameters

Program Overview

The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.

The main question[s] it aims to answer are:

  • the recommended dose for Phase 2
  • to evaluate the safety and tolerability of the combination therapy
  • to determine the pharmacokinetics of TNG260
  • to evaluate the initial antineoplastic activity

Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

Description

This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of TNG260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Is ≥18 years of age at the time of signature of the main study ICF.
  • Has ECOG performance status of 0 or 1.
  • Has measurable disease based on RECIST v1.1.
  • All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytical method
  • Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor.
  • 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 Criteria

  • Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its excipients
  • 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 TNG260
  • Active prior or concurrent malignancy.
  • Central nervous system metastases associated with progressive neurological symptoms
  • Current active liver disease from any cause
  • Clinically relevant cardiovascular disease
  • A female patient who is pregnant or lactating

Get This Program In Your Inbox

You can sign up and apply your patients for this program.