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A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an anti-LAG-3 Monoclonal Antibody, alone and in combination with an anti-PD-1 in Patients with Advanced Solid Tumors
This purpose of this study is to evaluate the anti-LAG-3 antibody of TSR-033 alone and in combination with anti-PD-1. The study will be conducted in 2 parts, with Part 1 consisting of dose escalation to determine the recommended phase 2 dose (RP2D) of TSR-033 as a single agent (Part 1a) and in combination with an anti-PD-1 antibody (Part 1c). Part 2 of the study will evaluate the anti-tumor activity of TSR-033 in combination with an anti-PD-1 in participants.
Primary: Part 1: Dose Escalation Cohorts: - To define the recommended Phase 2 dose (RP2D) and schedule of TSR-033 as monotherapy and in combination with TSR-042 (anti-PD-1) - To evaluate the safety and tolerability of TSR-033 as monotherapy and in combination with TSR-042 in patients with advanced solid tumors Part 2: Dose Expansion Cohorts: - To evaluate the anti-tumor activity of TSR-033 in combination with TSR-042 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 - To confirm the RP2D and schedule TSR-033 in combination with TSR-042 Secondary: In Part 1 and Part 2, unless otherwise specified: - To characterize the PK of TSR-033 when given alone and in combination with TSR-042 - To characterize the PK of TSR-042 when given in combination with TSR-033 - To evaluate the immunogenicity of TSR-033 - To evaluate additional measures of clinical benefit, including − ORR by RECIST v 1.1 for patients in Part 1 − Duration of response by RECIST v 1.1 − Disease control rate by RECIST v 1.1 − Progression-free survival by RECIST v 1.1 − Overall survival Exploratory: - To characterize the PDy profile of TSR-033 - To evaluate the immunogenicity of TSR-042 in (Part 1c and Part 2) - To identify a biomarker-based patient population that would derive clinical benefit from TSR-033 treatment based on the pre-treatment profile of TILs, tumor characteristics, and/or circulating biomarkers. - To explore changes in biomarkers (eg, immune cells, cytokines or chemokines in the tumor and circulating biomarkers in the blood following treatment with TSR-033 and correlate with clinical benefit - To explore additional clinical efficacy outcomes by irRECIST