A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
UCLA Hematology/Oncology
RECRUITING
Santa Monica
Colorado
SCRI at HealthOne
RECRUITING
Denver
Florida
Florida Cancer Specialists
RECRUITING
Sarasota
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
Henry Ford Health System
RECRUITING
Detroit
START MidWest
RECRUITING
Grand Rapids
New York
NYU Langone Hematology Oncology Associates-Mineola
RECRUITING
Mineola
New York University Langone Health
RECRUITING
New York
Tennessee
Sarah Cannon Tennessee Oncology
RECRUITING
Nashville
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Contact Information
Primary
Adam Crystal, MD, PhD
clinicaltrials@tangotx.com
8573204899
Time Frame
Start Date:2023-06-12
Estimated Completion Date:2026-06
Participants
Target number of participants:126
Treatments
Experimental: Dose Escalation
Participants with STK11-mutant solid tumors will receive escalating doses of TNG260 in combination with pembrolizumab to estimate the MTD
Experimental: Dose Expansion in NSCLC with KRAS Mutation
Participants with STK11-mutant and KRAS-mutant NSCLC (squamous and non squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab
Experimental: Dose Expansion in NSCLC with KRAS Wild type
Participants with STK11-mutant and KRAS-wild type NSCLC (squamous and non-squamous) will receive TNG260 at the identified RP2D in combination with pembrolizumab
Experimental: Dose Expansion in Advanced or Metastatic Solid Tumors
Participants with STK11-mutant solid tumors (including but not limited to pancreatic, endometrial, cervical, breast, and carcinoma of unknown primary) will receive TNG260 at the identified RP2D in combination with pembrolizumab