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A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
NCT02817633 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Nivolumab
- DRUG TSR-042
- DRUG TSR-022
- DRUG TSR-033
Study Locations (20)
California
- GSK Investigational Site — Encinitas
- GSK Investigational Site — Fountain Valley
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — San Marcos
- GSK Investigational Site — Whittier
Arizona
- GSK Investigational Site — Goodyear
- GSK Investigational Site — Scottsdale
- GSK Investigational Site — Tucson
- GSK Investigational Site — Tucson
Florida
- GSK Investigational Site — Jacksonville
- GSK Investigational Site — Miami
- GSK Investigational Site — Sarasota
- GSK Investigational Site — Tampa
Colorado
- GSK Investigational Site — Aurora
- GSK Investigational Site — Aurora
- GSK Investigational Site — Denver
Connecticut
- GSK Investigational Site — New Haven
District of Columbia
- GSK Investigational Site — Washington D.C.
Georgia
- GSK Investigational Site — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 463 participants |
| Start Date | 2016-07-08 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02817633
The ClinicalTrials.gov registry entry for NCT02817633 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 463 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 5 interventions — of which Docetaxel 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: NCT02817633 reports 20 study locations spanning 7 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 NCT02817633 about?
NCT02817633 is a clinical study titled "A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)". 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 T...
What is the current status of trial NCT02817633?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 463 participants. The study started on 2016-07-08. Estimated completion is 2027-03-01.
What conditions does trial NCT02817633 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 NCT02817633?
The interventions under investigation include: Docetaxel (DRUG), Nivolumab (DRUG), TSR-042 (DRUG), TSR-022 (DRUG), TSR-033 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02817633?
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 NCT02817633 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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