NCT02817633

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

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2016-07-08
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2016-06-29
• Last updated: 2025-10-28

Locations

89 sites across 3 countries: United States, South Korea, Spain

Regulatory

• FDA-regulated drug study