Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTango Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- TNG260
- Pembrolizumab
Treatment groups
126 Participants
are divided into 4 treatment groupsLocations
13California
UCLA Hematology/Oncology90404, Santa Monica United States
Colorado
SCRI at HealthOne80218, Denver United States
Florida
Florida Cancer Specialists34232, Sarasota United States
Massachusetts
Dana Farber Cancer Institute02215, Boston United States
Sponsors and collaborators
Tango Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov