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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 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.

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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

Neoplasms

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

FieldValue
Enrollment Target 463 participants
Start Date 2016-07-08
Est. Completion 2027-03-01
Phase Phase 1

Sponsor

Tesaro

26 total trials

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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, categorized as Phase 1. The registered enrollment target is 463 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,618-participant average among 158 other Neoplasms trials with a reported enrollment target (71% 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 5 interventions - of which Docetaxel is the first listed.

NCT02817633 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.