RecruitingPhase 1Phase 2NCT05887492

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

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors


Sponsor

Tango Therapeutics, Inc.

Enrollment

126 participants

Start Date

Jun 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TNG260 — either alone or combined with an anti-PD-1 immunotherapy drug — in people with advanced solid tumors that have a mutation in the STK11 gene. This mutation is often linked to poor response to immunotherapy. **You may be eligible if...** - You are 18 years old or older - You have a confirmed advanced or metastatic solid tumor with a documented STK11 mutation - Your cancer is measurable on imaging - Your general health is good (ECOG 0 or 1) - Your organ function (liver, kidneys) meets the required thresholds **You may NOT be eligible if...** - You have a known allergy or sensitivity to TNG260 or to PD-1/PD-L1 antibodies - You have uncontrolled brain metastases - You have active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have had certain prior treatments that could interact with this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTNG260

CoREST inhibitor, administered orally

DRUGPembrolizumab

Pembrolizumab, an anti-PD-1 antibody, administered intravenously


Locations(13)

UCLA Hematology/Oncology

Santa Monica, California, United States

SCRI at HealthOne

Denver, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

START MidWest

Grand Rapids, Michigan, United States

NYU Langone Hematology Oncology Associates-Mineola

Mineola, New York, United States

New York University Langone Health

New York, New York, United States

Sarah Cannon Tennessee Oncology

Nashville, Tennessee, United States

US Oncology Investigational Products Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

US Oncology Investigational Products Center

Norfolk, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05887492


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