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ACTIVE NOT RECRUITING Phase 1

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

NCT02715284 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • BIOLOGICAL Dostarlimab

Study Locations (20)

California

  • GSK Investigational Site — Encinitas
  • GSK Investigational Site — La Jolla
  • GSK Investigational Site — Los Angeles
  • GSK Investigational Site — Newport Beach
  • GSK Investigational Site — San Francisco
  • GSK Investigational Site — San Marcos
  • GSK Investigational Site — Santa Monica

Arizona

  • GSK Investigational Site — Goodyear
  • GSK Investigational Site — Scottsdale

Florida

  • GSK Investigational Site — Miami
  • GSK Investigational Site — Tampa

Alabama

  • GSK Investigational Site — Birmingham

Arkansas

  • GSK Investigational Site — Fayetteville

District of Columbia

  • GSK Investigational Site — Washington D.C.

Georgia

  • GSK Investigational Site — Augusta

Illinois

  • GSK Investigational Site — Chicago

Trial Details

FieldValue
Enrollment Target 730 participants
Start Date 2016-03-07
Est. Completion 2027-01-25
Phase Phase 1

Sponsor

Tesaro

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02715284

The ClinicalTrials.gov registry entry for NCT02715284 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 730 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention — of which Dostarlimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02715284 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02715284 about?

NCT02715284 is a clinical study titled "Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors". 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 wit...

What is the current status of trial NCT02715284?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 730 participants. The study started on 2016-03-07. Estimated completion is 2027-01-25.

What conditions does trial NCT02715284 study?

This clinical trial studies the following conditions: Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02715284?

The interventions under investigation include: Dostarlimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02715284?

This trial is sponsored by Tesaro, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02715284 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial