drugset / Trial / NCT02817633
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |