NCT03396497

Study of LYC-55716 With Pembrolizumab in Adult Subjects With Non-Small Cell Lung Cancer

A Multicenter, Open-Label Study of LYC-55716 in Combination With Pembrolizumab in Adult Subjects With Metastatic Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Lycera Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	LYC-55716	Continuous twice daily administration of LYC-55716 in 28 day treatment cycles.
DRUG	Pembrolizumab	Pembrolizumab administered every 3 weeks as prescribed as standard of care by the investigator in accordance with the package insert.

Timeline

• Start date: 2018-08-03
• Primary completion: 2019-10-20
• Completion: 2019-10-20
• First posted: 2018-01-11
• Last updated: 2019-09-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study