Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

Summary

Participation Requirements

Description

This is a Phase I/Ib, multi-center, open-label study to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of LHC165 single agent and in combination with the Programmed Cell Death Protein-1 (PD-1) checkpoint inhibitor PDR001. Two d...

This is a Phase I/Ib, multi-center, open-label study to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of LHC165 single agent and in combination with the Programmed Cell Death Protein-1 (PD-1) checkpoint inhibitor PDR001. Two different dosing schedules will be explored for LHC165 single agent and in combination with PDR001 resulting in four dose escalation groups in accessible tumors. The first dose escalation group will receive LHC165 via intratumoral injection on Days 1 and 15 of Cycles 1, 2, 5, and 6. If biological activity is seen in the LHC165 single agent group on the biweekly dosing schedule, another dose escalation group using a monthly dosing schedule will be opened where patients will receive LHC165 via intratumoral injection on Day 1 of Cycles 1, 2, 5, and 6. In addition, once two safe doses are observed in the LHC165 single agent group on the biweekly dosing schedule, an LHC165 combination with PDR001 dose escalation group will be opened using the biweekly dosing schedule. If biological activity is seen in the LHC165 combination with PDR001 group on the biweekly dosing schedule, another dose escalation group for the combination using a monthly dosing schedule will be opened. Once the recommended dose for the LHC165 single agent and in combination with PDR001 is identified, the respective expansion parts of the study will open.

Tracking Information