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NCT05887492 | RECRUITING | Non Small Cell Lung Cancer

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

Tango Therapeutics, Inc.

Brief 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.

Condition or disease

Non Small Cell Lung Cancer

Solid Tumors, Adult

Lung Cancer

Lung Adenocarcinoma

Intervention/treatment

TNG260

Pembrolizumab

Phase

PHASE1

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 126 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-06-12
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

Location Details

NCT05887492

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

UCLA Hematology/Oncology

Santa Monica, California, United States, 90404

RECRUITING

United States, Colorado

Scri at Healthon

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

Florida Cancer Specialists

Sarasota, Florida, United States, 34232

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Henry Ford Health System

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Road cancer

START MidWest

Grand Rapids, Road cancer, United States, 49546

RECRUITING

United States, New York

New York University Langone Health

New York, New York, United States, 10016

RECRUITING

United States, Tennessee

Sarah Cannon Tennessee Oncology

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

NEXT Oncology Virginia

Fairfax, Virginia, United States, 22031