Have you or your loved ones been diagnosed with neoplasms?

You may be eligible to participate in a neoplasms clinical trial.

Have you or your loved ones been diagnosed with neoplasms? You may be eligible to participate in a neoplasms clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Neoplasms Clinical Trial
NCT02715284 | Phase 1 | Interventional
Tesaro Inc
Sponsored by
Tesaro Inc

Have you or your loved ones been diagnosed with neoplasms?

You may be eligible to participate in a neoplasms clinical trial.

Have you or your loved ones been diagnosed with neoplasms? You may be eligible to participate in a neoplasms clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 740 Participants

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.