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NCT02817633 · ClinicalTrials.gov registry record · Phase 1
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
A Phase 1 study of Neoplasms, sponsored by Tesaro.
- Active
- Registry status
- Phase 1
- Development phase
- 463
- Enrollment target
- 20
- Study locations
NCT02817633: Active Phase 1 study of Neoplasms, sponsored by Tesaro.
NCT02817633 is a Phase 1 study of Neoplasms that is active but no longer recruiting, run by Tesaro. The registered enrollment target is 463 participants, below the 1,618-participant average among 158 other Neoplasms trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02817633, a Phase 1 study of Neoplasms, is active but no longer recruiting, sponsored by Tesaro.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 463 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT02817633 still lists
NCT02817633 is an interventional study that assigns participants to a tested intervention. The registered 463 participants enrollment target is mid-sized for trials with a published cap, below the 1,618-participant average among 158 other Neoplasms trials with a reported enrollment target (71% lower).
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.
NCT02817633 names 20 study sites across 7 states, led by California, Arizona, Florida.
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.
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).
Who is sponsoring clinical trial NCT02817633?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02817633's enrollment target sits among peer trials
463 25th of 158 higher than 134 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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