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Clinical Trial 18906

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT02817633

Phase: Phase I
Principal Investigator: Eroglu, Zeynep

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Study Title

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.



Immunotherapy; Therapy (NOS)


BMS-936558 (Nivolumab); Nivolumab (Opdivo); TSR-022 (); TSR-033 (); TSR-042 (Dostarlimab); Taxotere (docetaxel); docetaxel ()

Inclusion Criteria

  • Participant with advanced or metastatic solid tumor and has disease progression or treatment intolerance after treatment with available therapies
  • Agreement to biopsies before and during treatment, depending on study part
  • Female Participants must have a negative pregnancy test or be of non-childbearing potential.
  • Required that female Participants of childbearing potential use a highly effective of contraception with their partner
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 with adequate hematologic and organ function

  • Exclusion Criteria

  • Received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD1-ligand-1 (anti-PD-L1) or anti-PD-1 ligand-2 (anti-PD-L2) agent within 3 weeks prior to initiation of study treatment depending on study part
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-TIM-3 or anti-LAG-3 (Part 1e)
  • Prior treatment with an anti-LAG-3 or anti-TIM-3 (Part 2)
  • Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis or known malignancy that progressed or required active treatment within the last 2 years
  • Pregnant, breastfeeding, or expecting to conceive children within 150 days after the last dose of study treatment
  • History of human immunodeficiency virus (HIV), pneumonitis, active Hepatitis B or Hepatitis C, or ≥Grade 3 immune-related AE with prior immunotherapy
  • Autoimmune disease that required systemic treatment
  • Not recovered from radiation and chemotherapy-induced AEs
  • Participated in another investigational study (drug or device) within 4 weeks of first dose
  • Received prior anticancer therapy within 21 days of first dose
  • Not recovered from AEs and/or complications from major surgery prior to first dose
  • Received a vaccine within 7 days of first dose
  • Participants with radiologic or clinical progression ≤ 8 weeks after initiation of a prior anti-PD-1 or anti-PD-L1 antibody (Cohort 2D)
  • Participants with known EGFR mutation, ALK translocation or ROS1 mutation (Cohort 2D)

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