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Study of the drug TNG260 and an Immunotherapy in Advanced Solid Tumors With a STK11 Mutation

Clinicaltrials.gov identifier:
NCT05887492

Treatment
This is a treatment study enrolling people with advanced or metastatic solid tumors with known STK11 mutations

Study Contact Information:

For additional information, please contact:

Name: Adam Crystal, MD, PhD

Phone Number: 8573204899

Email: [email protected]

Study of the drug TNG260 and an Immunotherapy in Advanced Solid Tumors With a STK11 Mutation

About the Study

The study is designed to find the safest dose of a drug called TNG260, given along with a standard dose of the drug pembrolizumab, in people with a genetic mutation and advanced or solid tumors including breast, cervial, endometrial and pancreatic cancer.

What the Study Involves

Participants will take the drug TNG260 by mouth and Pembrolizumab intravenously for 42 days or until their cancer gets worse, the treatment causes severe side effects, or they choose to stop the study.

Participants will have samples collected including blood, biopsies of their tumor and/or imaging to determine their response to the treatment.

California

City: Santa Monica RECRUITING
Facility: UCLA Hematology/Oncology
Contact Info:
Jonathan Goldman, MD

Colorado

City: Denver RECRUITING
Facility: SCRI at HealthOne
Contact Info:
Gerald Falchook, MD

Florida

City: Sarasota RECRUITING
Facility: Florida Cancer Specialists
Contact Info:
Judy Wang, MD

Massachusetts

City: Boston RECRUITING
Facility: Dana Farber Cancer Institute
Contact Info:
Mark Awad, MD, PhD

Michigan

City: Detroit RECRUITING
Facility: Henry Ford Health System
Contact Info:
Shiresh Gadgeel, MD

City: Grand Rapids RECRUITING
Facility: START MidWest
Contact Info:
Manish Sharma, MD

New York

City: New York RECRUITING
Facility: New York University Langone Health
Contact Info:
Salman Punekar, MD

Tennessee

City: Nashville RECRUITING
Facility: Sarah Cannon Tennessee Oncology
Contact Info:
David Spigel, MD

Texas

City: Houston RECRUITING
Facility: The University of Texas MD Anderson Cancer Center
Contact Info:
Ferdinandos Skoulidis, MD

Virginia

City: Fairfax RECRUITING
Facility: NEXT Oncology Virginia
Contact Info:
Alex Spira, MD

This Study is Open To:

People 18 years of age or older who:

have advanced or solid tumor with a genetic mutation
have adequate kidney and liver function
have a negative blood pregnancy test prior to enrollment in the study

This Study is Not Open To:

People younger than 18 years old and:

have allergies, hypersensitivity, or intolerance to the drug TNG260 or the drug pembrolizumab
have an active infection or other severe illnesses that would interfere with participation
are currently participating in other clinical trials
have symptomatic brain
have active liver or heart disease
have issues with gastrointestinal function such as abdominal pain, bloating, diarrhea, constipation, nausea, vomiting, and difficulty swallowing that will interfere with absorption of oral medications
are pregnant or lactating