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

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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