Last updated on January 2020

Study of TSR-033 With an Anti-PD-1 in Patients With Advanced Solid Tumors

Brief description of study

This is a multicenter, open-label, first-in-human Phase 1 study evaluating TSR-033, an anti-LAG-3 Monoclonal Antibody, alone and in combination with an anti-PD-1 in Patients with Advanced Solid Tumors in a broad range of solid tumors. Patients with disease types selected for evaluation in this study are expected to derive clinical benefit with addition of an anti-PD-1. The study will be conducted in two parts: dose escalation and cohort expansion.

Detailed Study Description

This is a multi-center, open-label, first-in-human, Phase 1 study evaluating the anti-LAG-3 antibody of TSR-033 alone and in combination with anti-PD-1. The study will be conducted in 2 parts, with Part 1 consisting of dose escalation to determine the RP2D of TSR-033 as a single agent (Part 1a) and in combination with an anti-PD-1 antibody (Part 1c). RP2D decisions will be based on the occurrence of dose-limiting toxicities (DLTs), PK, as well as PDy data. These regimens will be evaluated in patients with advanced solid tumors who have limited available treatment options as determined by the Investigator.

Part 2 of the study will evaluate for Cohort A the anti-tumor activity of TSR-033 in combination with an anti-PD-1 in patients. The safety and tolerability of TSR-033 and dostarlimab added to either mFOLFOX6 and bevacizumab or FOLFIRI and bevacizumab in patients with stage IV MSS-CRC will be evaluated for patients in Cohort B.

Clinical Study Identifier: NCT03250832

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Gustave Roussy

Villejuif, France
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