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ACTIVE NOT RECRUITING
NCT02715284
PHASE1

Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

Sponsor: Tesaro, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

730

Start Date

2016-03-07

Completion Date

2027-01-25

Last Updated

2026-01-13

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Dostarlimab

Dostarlimab (160 mg, 20 mg/mL; or 500 mg, 50 mg/mL) is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2). Dostarlimab will be administered via a 30 minute IV infusion on Day 1 and Day 15 of each cycle in Part 1. For additional patients enrolled specifically to better characterize the PK/PDy profile in Part 1, dostarlimab administration during Cycle 1 will only occur on Day 1 with the second dose administered on Cycle 2/Day 1 and Q2W thereafter. For Part 2A and 2B, dostarlimab will be administered on Day 1 of each treatment cycle. Cycle duration for Q3W dosing is 21 days and Q6W dosing is 42 days.

Locations (105)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Goodyear, Arizona, United States

GSK Investigational Site

Scottsdale, Arizona, United States

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Fayetteville, Arkansas, United States

GSK Investigational Site

Encinitas, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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San Francisco, California, United States

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San Marcos, California, United States

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Santa Monica, California, United States

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Washington D.C., District of Columbia, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Fairway, Kansas, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Kansas City, Missouri, United States

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Farmington, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Jamaica, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Hilliard, Ohio, United States

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Hilliard, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

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Hořovice, Czechia

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Zlín, Czechia

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Copenhagen, Denmark

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Odense C, Denmark

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Caen, France

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Lille, France

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Marseille, France

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Paris, France

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Paris, France

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Saint-Herblain, France

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Villejuif, France

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Milan, Italy

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Milan, Italy

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Milan, Italy

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Modena, Italy

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Naples, Italy

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Roma, Italy

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Verona, Italy

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Gdynia, Poland

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Lublin, Poland

GSK Investigational Site

Olsztyn, Poland

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Olsztyn, Poland

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Torun, Poland

GSK Investigational Site

Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Girona, Spain

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Girona, Spain

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Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

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Madrid, Spain

GSK Investigational Site

Málaga, Spain

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Pamplona, Spain

GSK Investigational Site

Santiago de Compostela, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Zaragoza, Spain

GSK Investigational Site

Aberdeen, United Kingdom

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London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

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Manchester, United Kingdom

GSK Investigational Site

Newcastle upon Tyne, United Kingdom

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Oxford, United Kingdom

GSK Investigational Site

Sutton, United Kingdom