Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

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.

Eligibility

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

Conditions5

Locations13 sites

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