Combining TNG260 with pembrolizumab for treating 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
This study is testing a new treatment combining TNG260 and pembrolizumab to see if it can help people with advanced solid tumors that have an STK11 mutation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tango Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 13 sites (Santa Monica, California and 12 other locations) |
| Trial ID | NCT05887492 on ClinicalTrials.gov |
What this trial studies
This interventional clinical trial aims to evaluate the safety, tolerability, and effectiveness of TNG260, a CoREST inhibitor, in combination with pembrolizumab for patients with advanced solid tumors harboring an STK11 mutation. The study is designed as a first-in-human Phase 1/2 trial, which will involve dose escalation to determine the maximum tolerated dose and the recommended dose for Phase 2. Participants will receive the treatment until they experience adverse effects, disease progression, or choose to withdraw from the study. The trial will also assess the pharmacokinetics of TNG260 and its initial antineoplastic activity.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with locally advanced or metastatic solid tumors that have a documented STK11 mutation.
Not a fit: Patients without an STK11 mutation or those with uncontrolled intercurrent illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with STK11 mutated solid tumors, potentially improving their outcomes.
How similar studies have performed: While this approach is novel in its specific combination, similar studies targeting STK11 mutations have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Santa Monica, California and 12 other locations
- UCLA Hematology/Oncology — Santa Monica, California, United States (Recruiting)
- SCRI at HealthOne — Denver, Colorado, United States (Recruiting)
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- START MidWest — Grand Rapids, Michigan, United States (Recruiting)
- NYU Langone Hematology Oncology Associates-Mineola — Mineola, New York, United States (Recruiting)
- New York University Langone Health — New York, New York, United States (Recruiting)
- Sarah Cannon Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
- US Oncology Investigational Products Center — Dallas, Texas, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Oncology Virginia — Fairfax, Virginia, United States (Recruiting)
- US Oncology Investigational Products Center — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Adam Crystal, MD, PhD
- Email: clinicaltrials@tangotx.com
- Phone: 8573204899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.