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A Phase 1 Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Tesaro, Inc.
Sponsor:
Information provided by (Responsible Party):
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT02817633
First received: June 22, 2016
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 (T cell immunoglobulin and mucin containing protein-3) antibody TSR-022, as a monotherapy and in combination with an anti-PD-1 antibody, in patients with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts: dose escalation and cohort expansion.

Condition Intervention Phase
Advanced or Metastatic Solid Tumors Drug: TSR-022 Drug: anti-PD-1 antibody Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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

Further study details as provided by Tesaro, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of TSR-022 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors [ Time Frame: Part 1 Dose Escalation - Approximately 2 years ]
  • 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) v. 1.1 [ Time Frame: Part 2 Expansion - Approximately 2 years ]
  • Recommended Phase 2 dose (RP2D) and schedule as monotherapy and in combination with an anti-PD-1 antibody [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]

Secondary Outcome Measures:
  • Safety and tolerability of TSR-022 using CTCAE v.4.03 [ Time Frame: Part 2 - Approximately 2 years ]
    Incidence of treatment-emergent AEs (TEAEs), SAEs, immune-related AEs (irAEs), TEAEs leading to death, and AEs leading to discontinuation occurring while patients are on treatment or up to 90 days after the last dose of study drug as assessed by CTCAE v4.03

  • Overall Response Rate (ORR) by RECIST v. 1.1 (Part 1) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • ORR by immune-related RECIST (irRECIST) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • Duration of response (DOR) by RECIST v 1.1 [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • Disease control rate (DCR) by RECIST v 1.1 and by irRECIST [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • Overall survival (OS) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: AUC, 0-last assessment [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: AUC, 0 to infinity [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: AUC at steady state [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: Minimum Concentration (Cmin) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: Maximum Concentration (Cmax) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: Clearance (CL) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: Cmin at steady state (Cmin,ss) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: Cmax at steady state (Cmax, ss) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: Volume of Distribution (Vz) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • PK Parameter: terminal half-life (t1/2) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  • Pharmacodynamic profile as assessed by receptor occupancy [ Time Frame: Part 1 and 2 - Approximately 4 years ]
  • Immunogenicity as assessed by the presence of anti-drug antibodies [ Time Frame: Part 1 and 2 -Approximately 4 years ]

Estimated Enrollment: 447
Study Start Date: July 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1- Dose Escalation

1a: Dose escalation TSR-022 alone

1b: Dose escalation TSR-022 in combination with anti-PD-1 antibody

1c: Phase 2 recommended TSR-022 dose in combination with anti-PD-1 antibody

Drug: TSR-022
TSR-022 is a humanized monoclonal IgG4 antibody
Drug: anti-PD-1 antibody
Experimental: Part 2- Expansion Cohorts
Part 2 of the study will further explore the safety and clinical activity of TSR-022 as monotherapy and in combination with anti-PD-1 antibody in patients with select tumor types
Drug: TSR-022
TSR-022 is a humanized monoclonal IgG4 antibody
Drug: anti-PD-1 antibody

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Partial Inclusion Criteria:

  • Patient 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 patients must have a negative serum pregnancy test or be of non-childbearing potential.
  • Two methods of contraception required for males and females of childbearing potential
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 and adequate organ function

Partial 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 8 weeks prior to initiation of study treatment depending on study part
  • 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 projected duration of study
  • History of human immunodeficiency virus (HIV), interstitial lung disease, active Hepatitis B or Hepatitis C
  • Autoimmune disease that required systemic treatment
  • Not recovered from radiation and chemotherapy-induced AEs or received blood transfusion
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02817633

Contacts
Contact: Clinical Trial Management Group ClinicalTrialsTSR022@tesarobio.com

Locations
United States, Arizona
Recruiting
Goodyear, Arizona, United States
United States, California
Recruiting
Los Angeles, California, United States
United States, Colorado
Recruiting
Denver, Colorado, United States
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
United States, Florida
Recruiting
Sarasota, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
Sponsors and Collaborators
Tesaro, Inc.
Investigators
Study Director: Dmitri Bobilev, MD Tesaro, Inc.
  More Information

Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02817633     History of Changes
Other Study ID Numbers: 4020-01-001
Study First Received: June 22, 2016
Last Updated: May 12, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Tesaro, Inc.:
Anitibodies
TSR-022
Advanced solid tumors
Metastatic solid tumors
Immunotherapy
PD-1
Anti-PD-1
colorectal cancer
non-small cell lung cancer
Melanoma

Additional relevant MeSH terms:
Neoplasms
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017