This is a Phase 1B study designed to assess the safety and tolerability of LYC-55716 given in combination with pembrolizumab to subjects with metastatic NSCLC, and to assess the combination for biologic and clinical activity in NSCLC.
Approximately 18 subjects across 5 US sites will be enrolled in the study. Subjects will enter a screening period of up to 28 days, followed by continuous twice daily administration of LYC-55716 in 28 day treatment cycles. Subjects will also be administered pembrolizumab every 3 weeks as prescribed as standard of care by the Investigator in accordance with the package insert. The study will begin with a run-in cohort of 3 subjects to assess the safety and tolerability of the LYC-55716/pembrolizumab combination. Subjects in the run-in cohort will be enrolled singly at intervals of not less than 7 days in order to monitor for adverse reactions to the combination. If no subjects in the run-in cohorts has a DLT, then the study may proceed to the main cohort (15 subjects). Subjects will receive combination treatment until clinically significant disease progression or unacceptable toxicity, or up to a maximum of 24 months. Primary Study Objectives: Run-in Cohort * Evaluate the safety and tolerability of the LYC-55716/pembrolizumab combination * Determine the dose of LYC-55716 that is adequately tolerated when used in combination with pembrolizumab Main Study Cohort • Further evaluate the safety and tolerability of the LYC-55716/pembrolizumab combination Secondary Study Objectives: Main Study Cohort * Evaluate the cellular immune response in paired tumor biopsy samples * Evaluate effects on circulating biomarkers in the blood of LYC-55716 with pembrolizumab * Determine the objective response rate * Determine the duration of response * Determine the progression-free survival (PFS) and overall survival (OS)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Continuous twice daily administration of LYC-55716 in 28 day treatment cycles.
Pembrolizumab administered every 3 weeks as prescribed as standard of care by the investigator in accordance with the package insert.
Lycera Investigational Site
Aurora, Colorado, United States
Lycera Investigational Site
Ann Arbor, Michigan, United States
Lycera Investigational Site
Nashville, Tennessee, United States
Lycera Investigational Site
Seattle, Washington, United States
Safety and tolerability will be assessed by the number of subjects with any treatment-emergent Adverse Events
Common terminology criteria for adverse events (CTCAE) will be used for AE assessment.
Time frame: 12 weeks
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