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
1 other identifier
interventional
126
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2023
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedStudy Start
First participant enrolled
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedNovember 18, 2025
July 1, 2025
2.6 years
April 18, 2023
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine the MTD and RP2D(s) (Phase 1 only)
To determine the MTD and RP2D(s) of TNG260 when administered in combination with pembrolizumab
42 days
Measure antitumor activity using RECIST 1.1 (Phase 2 only)
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
12 weeks
Secondary Outcomes (8)
Measure antitumor evidence of TNG260 + pembrolizumab antineoplastic activity by RECIST 1.1 (Phase 1 only)
12 weeks
Characterize Area Under the Curve (AUC) of TNG260
37 days
Characterize the time to achieve Time to Maximal Concentration (Tmax) of TNG260
37 days
Characterize Maximum Observed Plasma Concentration (Cmax) of TNG260
37 days
Characterize Terminal Half-life (T1/2) of TNG260
37 days
- +3 more secondary outcomes
Study Arms (4)
Dose Escalation
EXPERIMENTALParticipants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD
Dose Expansion in NSCLC with KRAS Mutation
EXPERIMENTALParticipants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab
Dose Expansion in NSCLC with KRAS Wild type
EXPERIMENTALParticipants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab
Dose Expansion in Advanced or Metastatic Solid Tumors
EXPERIMENTALParticipants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab
Interventions
CoREST inhibitor, administered orally
Pembrolizumab, an anti-PD-1 antibody, administered intravenously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
START MidWest
Grand Rapids, Michigan, 49546, United States
NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York, 11501, United States
New York University Langone Health
New York, New York, 10016, United States
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, 37203, United States
US Oncology Investigational Products Center
Dallas, Texas, 75246, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031, United States
US Oncology Investigational Products Center
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adam Crystal, MD, PhD
Tango Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2023
First Posted
June 2, 2023
Study Start
June 12, 2023
Primary Completion
January 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
November 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share