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A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors
This study is divided into 2 parts. The purpose of this research study is to: Part 1: Evaluate the safety and tolerability of TSR-022, the Study Drug. Part 2: Evaluate the ability of TSR-022 when taken alone or in combination with nivolumab (Opdivo®) to make the cancer smaller.
Primary Objectives: Part 1 - Dose Escalation Cohorts: - To evaluate the safety and tolerability of TSR-022 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors. - Part 1a: TSR-022 as monotherapy. - Part 1b: TSR-022 in combination with nivolumab. - To define the recommended Phase 2 dose (RP2D) and schedule of TSR-022 as monotherapy and in combination with nivolumab. Part 2 - Expansion Cohorts: - To evaluate the anti-tumor activity of TSR-022 in patients with solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as monotherapy and in combination therapy with nivolumab. - To confirm the RP2D and schedule of TSR-022 as monotherapy and in combination with nivolumab. Secondary Objectives: Part 2 - Expansion Cohorts: - To characterize the safety and tolerability of TSR-022 using CTCAE v.4.03. Part 1 and Part 2: - To characterize the pharmacokinetic (PK) profile of TSR-022. - To characterize the pharmacodynamic (PDy) profile of TSR-022. - To evaluate the immunogenicity of TSR-022. - To evaluate additional measures of clinical benefit, including: − ORR by RECIST v 1.1 for patients in Part 1; − ORR by immune-related RECIST (irRECIST); − Duration of response (DOR) by RECIST v 1.1; − Disease control rate (DCR) by RECIST v 1.1 and by irRECIST; − Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST; − Overall survival (OS). Exploratory Objectives: - To identify a biomarker-based patient population that would derive clinical benefit from TSR-022 treatment based on the pre-treatment profile of tumor infiltrating lymphocytes (TILs), tumor characteristics, and/or circulating biomarkers. - To explore changes in biomarkers (eg, immune cells and immune proteins) in the tumor and circulating biomarkers in the blood following treatment with TSR-022 and correlate with clinical benefit.