Open
Actively Recruiting
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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
Join this Trial
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Study Stats
Protocol No.
23-001152
Category
Lung Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica