Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT02715284. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02715284
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 729 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 6, 2016
- Primary completion
- May 17, 2026
- Completion
- Apr 13, 2028
- Last update posted
- Aug 24, 2026
2016 – 2028
United States locations
- U.S. sites
- 48
- U.S. states
- 26
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35233 | — |
| GSK Investigational Site | Goodyear | Arizona | 85338 | — |
| GSK Investigational Site | Scottsdale | Arizona | 85258 | — |
| GSK Investigational Site | Fayetteville | Arkansas | 72703 | — |
| GSK Investigational Site | Encinitas | California | 92024 | — |
| GSK Investigational Site | La Jolla | California | 92093 | — |
| GSK Investigational Site | Los Angeles | California | 90095 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | San Francisco | California | 94115 | — |
| GSK Investigational Site | San Marcos | California | 92069 | — |
| GSK Investigational Site | Santa Monica | California | 90403 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | Tampa | Florida | 33612 | — |
| GSK Investigational Site | Augusta | Georgia | 30912 | — |
| GSK Investigational Site | Chicago | Illinois | 60637 | — |
| GSK Investigational Site | Fairway | Kansas | 66205 | — |
| GSK Investigational Site | Scarborough | Maine | 04074 | — |
| GSK Investigational Site | Baltimore | Maryland | 21231 | — |
| GSK Investigational Site | Boston | Massachusetts | 02114 | — |
| GSK Investigational Site | Boston | Massachusetts | 02215 | — |
| GSK Investigational Site | Detroit | Michigan | 48201 | — |
| GSK Investigational Site | Kansas City | Missouri | 64111 | — |
| GSK Investigational Site | Farmington | New Mexico | 87401 | — |
| GSK Investigational Site | Albany | New York | 12208 | — |
| GSK Investigational Site | Brooklyn | New York | 11203 | — |
| GSK Investigational Site | Jamaica | New York | 11432 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | — |
| GSK Investigational Site | Cleveland | Ohio | 44106 | — |
| GSK Investigational Site | Columbus | Ohio | 43210 | — |
| GSK Investigational Site | Hilliard | Ohio | 43026 | — |
| GSK Investigational Site | Hilliard | Ohio | 43210 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | — |
| GSK Investigational Site | Providence | Rhode Island | 02905 | — |
| GSK Investigational Site | Dallas | Texas | 75230 | — |
| GSK Investigational Site | Dallas | Texas | 75290-9032 | — |
| GSK Investigational Site | San Antonio | Texas | 78229-3307 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84112 | — |
| GSK Investigational Site | Charlottesville | Virginia | 22903 | — |
| GSK Investigational Site | Seattle | Washington | 98104 | — |
| GSK Investigational Site | Seattle | Washington | 98195 | — |
| GSK Investigational Site | Spokane | Washington | 99202 | — |
| GSK Investigational Site | Spokane | Washington | 99204 | — |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02715284, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02715284 live on ClinicalTrials.gov.