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NCT02715284 · ClinicalTrials.gov registry record · Phase 1
Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors
A Phase 1 study of Neoplasms, sponsored by Tesaro.
- Active
- Registry status
- Phase 1
- Development phase
- 730
- Enrollment target
- 20
- Study locations
NCT02715284 is a Phase 1 study of Neoplasms that is active but no longer recruiting, run by Tesaro. The registered enrollment target is 730 participants, below the 1,617-participant average among 158 other Neoplasms trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT02715284, a Phase 1 study of Neoplasms, is active but no longer recruiting, sponsored by Tesaro.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 730 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2016-03-07 |
| Est. Completion | 2027-01-25 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 730 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,617-participant average among 158 other Neoplasms trials with a reported enrollment target (55% lower). The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
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.
NCT02715284 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Arizona, Florida.
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.
What interventions are being tested in trial NCT02715284?
The interventions under investigation include: Dostarlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02715284?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
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.
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