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ACTIVE NOT RECRUITING
NCT02817633
PHASE1

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

Sponsor: Tesaro, Inc.

View on ClinicalTrials.gov

Summary

This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy.

Official title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

463

Start Date

2016-07-08

Completion Date

2027-03-01

Last Updated

2025-10-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

TSR-022

TSR-022 will be administered.

DRUG

Nivolumab

Nivolumab will be administered.

DRUG

TSR-042

TSR-042 will be administered.

DRUG

TSR-033

TSR-033 will be administered.

DRUG

Docetaxel

Docetaxel will be administered.

DRUG

Pemetrexed

Pemetrexed will be administered.

DRUG

Cisplatin

Cisplatin will be administered.

DRUG

Carboplatin

Carboplatin will be administered.

Locations (89)

GSK Investigational Site

Goodyear, Arizona, United States

GSK Investigational Site

Scottsdale, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Encinitas, California, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Marcos, California, United States

GSK Investigational Site

Whittier, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

New Haven, Connecticut, United States

GSK Investigational Site

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

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Sarasota, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

Arlington Heights, Illinois, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Niles, Illinois, United States

GSK Investigational Site

Iowa City, Iowa, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Pikeville, Kentucky, United States

GSK Investigational Site

Wheaton, Maryland, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Rochester, Minnesota, United States

GSK Investigational Site

Florissant, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Hackensack, New Jersey, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

The Bronx, New York, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Toledo, Ohio, United States

GSK Investigational Site

Eugene, Oregon, United States

GSK Investigational Site

Vancouver, Oregon, United States

GSK Investigational Site

Bethlehem, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

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Dallas, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

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Houston, Texas, United States

GSK Investigational Site

Longview, Texas, United States

GSK Investigational Site

McAllen, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Temple, Texas, United States

GSK Investigational Site

Tyler, Texas, United States

GSK Investigational Site

Fairfax, Virginia, United States

GSK Investigational Site

Kennewick, Washington, United States

GSK Investigational Site

Puyallup, Washington, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Tacoma, Washington, United States

GSK Investigational Site

Madison, Wisconsin, United States

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Girona, Spain

GSK Investigational Site

Jerez de la Frontera, Spain

GSK Investigational Site

L'Hospitalet de Llobrega, Spain

GSK Investigational Site

Las Palmas de Gran Canar, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Palma de Mallorca, Spain

GSK Investigational Site

Pamplona, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Zaragoza, Spain