RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-06-12
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05887492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is ≥18 years of age at the time of signature of the main study ICF.
  2. * Has ECOG performance status of 0 or 1.
  3. * Has measurable disease based on RECIST v1.1.
  4. * All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytical method
  5. * Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor.
  6. * Adequate organ function/reserve per local labs
  7. * Adequate liver function per local labs
  8. * Adequate renal function per local labs
  9. * Negative serum pregnancy test result at screening
  10. * Written informed consent must be obtained according to local guidelines
  1. * Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its excipients
  2. * Uncontrolled intercurrent illness that will limit compliance with the study requirements
  3. * Active infection requiring systemic therapy
  4. * Currently participating in or has planned participation in a study of another investigational agent or device
  5. * Impairment of GI function or disease that may significantly alter the absorption of oral TNG260
  6. * Active prior or concurrent malignancy.
  7. * Central nervous system metastases associated with progressive neurological symptoms
  8. * Current active liver disease from any cause
  9. * Clinically relevant cardiovascular disease
  10. * A female patient who is pregnant or lactating

Contacts and Locations

Study Contact

Adam Crystal, MD, PhD
CONTACT
8573204899
clinicaltrials@tangotx.com

Principal Investigator

Adam Crystal, MD, PhD
STUDY_DIRECTOR
Tango Therapeutics, Inc.

Study Locations (Sites)

UCLA Hematology/Oncology
Santa Monica, California, 90404
United States
SCRI at HealthOne
Denver, Colorado, 80218
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
New York University Langone Health
New York, New York, 10016
United States
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Tango Therapeutics, Inc.

  • Adam Crystal, MD, PhD, STUDY_DIRECTOR, Tango Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-06-12
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • STK11
  • KRAS
  • LKB1

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer
  • Solid Tumors, Adult
  • Endometrial Cancer
  • Pancreatic Cancer
  • Cervical Cancer
  • Breast Cancer
  • Carcinoma of Unknown Primary