A Phase II Trial of GT103 in Combination With Pembrolizumab in STK11 Mutant Non-Small Cell Lung Cancer (NSCLC)
Roswell Park Cancer Institute
Summary
This phase II trial tests how well GT103 in combination with pembrolizumab works in treating patients with STK11 mutant non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). GT103 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. GT103 targets the tumor cell-protein complement factor H found on some cancer cells and may provide specific anti-tumor activity that may help block the formation of growths that may become cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving GT103 in combination with pembrolizumab may kill more cancer cells and improve outcomes in patients with advanced or metastatic STK11 mutant non-small cell lung cancer.
Description
PRIMARY OBJECTIVE: I. To evaluate the 6-month (24 week) progression-free survival (PFS) rate of anti-CFH monoclonal antibody GT103 (GT103) in combination with pembrolizumab in patients with advanced/metastatic STK11 mutant non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate secondary efficacy endpoints (i.e., investigator-assessed objective response rate, 12-month survival rate, overall survival, duration of response, and disease control rate) of GT103 in combination with pembrolizumab in patients with advanced/metastatic STK11 mutant NSCLC. II. To evaluate the safety…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study treatment initiation. * Have pathologically confirmed diagnosis of STK11 mutant NSCLC. STK11 mutation will be based on subject's local clinically accredited laboratory testing (Clinical Laboratory Improvement Amendments \[CLIA\]-certified) using deoxyribonucleic acid (DNA) sequencing test. * Must have progressed on a pembrolizumab containing regimen and eligible for continuing pembrolizumab post-progression as determined by treating physician. * Absolute neu…
Interventions
- BiologicalAnti-CFH Monoclonal Antibody GT103
Given IV
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- ProcedureEchocardiography Test
Undergo ECHO
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- BiologicalPembrolizumab
Location
- Roswell Park Cancer InstituteBuffalo, New York