First-in-human Study of DRP-104 (Sirpiglenastat) as Single Agent and in Combination With Atezolizumab in Patients With Advanced Solid Tumors.

Summary

Participation Requirements

Description

This study will be conducted in 4 Parts: Part 1: Phase 1 single-agent dose escalation of DRP-104 (sirpiglenastat) in patients with advanced solid tumors to define the MTD (up to approximately 50 patients for each intravenous and subcutaneous cohort) Part 2, Once the MTD of DRP-104 for the IV and sub...

This study will be conducted in 4 Parts: Part 1: Phase 1 single-agent dose escalation of DRP-104 (sirpiglenastat) in patients with advanced solid tumors to define the MTD (up to approximately 50 patients for each intravenous and subcutaneous cohort) Part 2, Once the MTD of DRP-104 for the IV and subQ route of administration will be determined in Part 1, Part 2 will include 2 specific cohorts: Cohort 2 and 3 with one only selected formulation. Once the MTD of DRP-104 has been declared for either the IV or suQ cohort, Cohort 1 of Part 2 will separately expand for each cohort. -Cohort 1: Phase 1 single-agent safety expansion at the of DRP-104 in patients with advanced solid tumors (N= minimum of 14 and up to 20 patients for each intravenous and subcutaneous cohorts); The Sponsor will determine at completion of Phase 1 which route of administration will be further developed and continued for all subsequent Cohorts 2 and 3 and Parts 3 and Part 4 in combination with atezolizumab. Cohort 2: Phase 2a expansion at the of DRP-104 in patients with locally advanced or metastatic NSCLC whose tumors contain a KEAP1 mutation, NFE2L2 mutation and/or STK11 mutation (N=55 patients) Cohort 3: Phase 2a expansion at the MTD of DRP-104 in recurrent, unresectable or metastatic SCCHN (N=15-25 patients). Part 3: Phase 1 combination dose escalation of DRP-104 (sirpiglenastat) (with either IV or subcutaneous formulation selected) and atezolizumab in patients with advanced solid tumors previously treated with an anti-PD-1, anti PD-L1, and/or anti-CTLA-4 antibody, starting one dose level below the MTD of single-agent DRP-104 and in combination with atezolizumab (up to approximately N=12 patients). Part 4: Phase 1 combination safety expansion at the MTD of DRP-104 (with either IV or subcutaneous formulation selected)with atezolizumab in a similar patient population as the dose-escalation (N=14 patients).

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