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Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors
Sponsor: Tesaro, Inc.
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
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
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Goodyear, Arizona, United States
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Scottsdale, Arizona, United States
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Fayetteville, Arkansas, United States
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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
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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
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Olsztyn, Poland
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Olsztyn, Poland
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Torun, Poland
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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
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Zaragoza, Spain
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Aberdeen, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Oxford, United Kingdom
GSK Investigational Site
Sutton, United Kingdom