Open Actively Recruiting
Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
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.
- 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
- 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
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
- UCLA Santa Monica