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A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

NCT02817633 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2025-10-28

No results posted yet for this 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

  • Neoplasms

Interventions

DRUG

TSR-022

TSR-022 will be administered.

DRUG

Nivolumab

Nivolumab will be administered.

DRUG

TSR-042

TSR-042 will be administered.

DRUG

TSR-033

TSR-033 will be administered.

DRUG

Docetaxel

Docetaxel will be administered.

DRUG

Pemetrexed

Pemetrexed will be administered.

DRUG

Cisplatin

Cisplatin will be administered.

DRUG

Carboplatin

Carboplatin will be administered.

Sponsors & Collaborators

  • Tesaro, Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-08
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02817633 on ClinicalTrials.gov