drugset / Trial / NCT02817633

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

NCT02817633

Phase 1 Active not recruiting 463 enrolled Tesaro, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2016-07-08
Primary completion
2027-03-01
Completion
2027-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobolimab Monoclonal antibody
Background Carboplatin Small molecule
Background Cisplatin Other / unclassified
Background Docetaxel Small molecule
Background Dostarlimab Monoclonal antibody
Background Nivolumab Monoclonal antibody
Background Pemetrexed Small molecule
Background TSR-033 Monoclonal antibody

Indications