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Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05887492.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Name Not Available
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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
