Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors (NCT02715284)
A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (128 Sites)
Showing the first 25 of 128 sites.
- GSK Investigational Site — Birmingham, Alabama
- GSK Investigational Site — Goodyear, Arizona
- GSK Investigational Site — Scottsdale, Arizona
- GSK Investigational Site — Fayetteville, Arkansas
- GSK Investigational Site — Encinitas, California
- GSK Investigational Site — La Jolla, California
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — Newport Beach, California
- GSK Investigational Site — San Francisco, California
- GSK Investigational Site — San Marcos, California
- GSK Investigational Site — Santa Monica, California
- GSK Investigational Site — Washington D.C., District of Columbia
- GSK Investigational Site — Miami, Florida
- GSK Investigational Site — Tampa, Florida
- GSK Investigational Site — Augusta, Georgia
- GSK Investigational Site — Chicago, Illinois
- GSK Investigational Site — Fairway, Kansas
- GSK Investigational Site — Scarborough, Maine
- GSK Investigational Site — Baltimore, Maryland
- GSK Investigational Site — Boston, Massachusetts
- GSK Investigational Site — Boston, Massachusetts
- GSK Investigational Site — Detroit, Michigan
- GSK Investigational Site — Kansas City, Missouri
- GSK Investigational Site — Farmington, New Mexico
- GSK Investigational Site — Albany, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.