Study of the drug TNG260 and an Immunotherapy in Advanced Solid Tumors With a STK11 Mutation
https://www.facingourrisk.org/research-clinical-trials/study/333/study-of-the-drug-tng260-and-an-immunotherapy-in-advanced-solid-tumors-with-a-stk11-mutation
Clinicaltrials.gov identifier:
NCT05887492 (https://clinicaltrials.gov/show/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]
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 immunotherapy drug pembrolizumab, in people with a STK11 genetic mutation and advanced or metastatic 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.
This Study is Open To:
People 18 years of age or older who:
- have advanced or metastatic solid tumor with a STK11 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 immunotherapy 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 metastasis
- 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
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.