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drugset / Trial / NCT04418661

Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies

NCT04418661 ↗

Phase 1/2 Terminated 65 enrolled Sanofi Mirati Therapeutics Inc. · collabRevolution Medicines, Inc. · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

Primary Objectives: * Part 1 * To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. * To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors. * Part 2 * To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab. * Part 3A * To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC * To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC * Part 3B * To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC * Part 4 * To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab. * To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab. Secondary Objectives: * Part 1 * To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. * To estimate the anti-tumor effects of SAR442720 with pembrolizumab. * Part 2 * To assess the safety profile of SAR442720 combined with pembrolizumab. * To assess other indicators of anti-tumor activity. * To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. * Part 3A * To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. * To estimate the anti-tumor effects of SAR442720 with adagrasib * Part 3B * To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC. * To assess other indicators of anti-tumor activity. * To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. * Part 4 * To assess the safety and tolerability of SAR442720 formulations with pembrolizumab * To estimate the anti-tumor effects of SAR442720 with pembrolizumab.

Timeline

Start
2020-06-09
Primary completion
2024-04-04
Completion
2024-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Adagrasib Small molecule 400 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Vociprotafib Small molecule 100 mg Oral
Subject Vociprotafib Small molecule 140 mg Oral
Subject Vociprotafib Small molecule 200 mg Oral

Indications

metastatic neoplasm