A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) - Trial NCT06322693

Timeline & Enrollment

Primary Outcome

Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs),Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs),Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs),Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs),Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications,Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

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.

ICD-10 Classifications