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Clinical Trials in the USA / NCT05887492
Active, not recruiting Phase 1/2

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

NCT05887492 · tracked via the Priya Life Science USA tracker
Sponsor
Tango Therapeutics, Inc
Phase
Phase 1/2
Started
2023-06-12
Last updated
2026-07-06

Condition(s) studied

Non Small Cell Lung CancerSolid Tumors, AdultLung CancerLung Adenocarcinoma

Investigational drug(s) / intervention(s)

TNG260Pembrolizumab →

TNG260: CoREST inhibitor, administered orally

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Determine the MTD and RP2D(s) (Phase 1 only) — 42 days
    To determine the MTD and RP2D(s) of TNG260 when administered in combination with pembrolizumab
  • Measure antitumor activity using RECIST 1.1 (Phase 2 only) — 12 weeks
    To assess antineoplastic activity of TNG260 when administered in combination with pembrolizumab in participants with locally advanced unresectable or metastatic STK11-mutated solid tumors by measuring ORR, DOR, and PFS by RECIST 1.1

Trial sites (13)

FacilityCityRegionStatus
UCLA Hematology/Oncology Santa Monica California
SCRI at HealthOne Denver Colorado
Florida Cancer Specialists Sarasota Florida
Dana Farber Cancer Institute Boston Massachusetts
Henry Ford Health System Detroit Michigan
START MidWest Grand Rapids Michigan
NYU Langone Hematology Oncology Associates-Mineola Mineola New York
New York University Langone Health New York New York
Sarah Cannon Tennessee Oncology Nashville Tennessee
US Oncology Investigational Products Center Dallas Texas
The University of Texas MD Anderson Cancer Center Houston Texas
NEXT Oncology Virginia Fairfax Virginia
US Oncology Investigational Products Center Norfolk Virginia

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Tango Therapeutics, Inc. trials in the USA

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors Recruiting
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss Recruiting
Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients Recruiting

Other trials for the same condition

A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Recruiting
Evaluation of Improved Onboard Patient Imaging Active, not recruiting
Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients Active, not recruiting
Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung Active, not recruiting
Sample Collection for Ongoing Research and Product Evaluation Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05887492 on ClinicalTrials.gov ↗ ← All trials in the USA