Summary
This is a multi-center, open-label, first-in-human Phase 1 study evaluating the
anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042)
n participants with advanced solid tumors who have limited available treatment options.
The study will be conducted in 2 parts with Part 1 consisting of safety evaluation,
pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab.
Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab
and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at
any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on
emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A
(fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the
study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg
administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of
the study will examine the safety and clinical activity of dostarlimab in cohorts of
participants with specific types of advanced solid tumors.