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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tango Therapeutics, Inc.
• Treatments: Pembrolizumab

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