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

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ClinicalTrials.gov Identifier: NCT02817633
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Tesaro, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: TSR-022 Drug: anti-PD-1 antibody Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 627 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1- Dose Escalation

1a: Dose escalation TSR-022 alone

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

1c: TSR-022 dose in combination with an 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 :
  1. 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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
  • Required that female patients of childbearing potential use two methods of contraception with their partner
  • 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, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Pennsylvania
Recruiting
Pittsburgh, Pennsylvania, 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
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Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02817633     History of Changes
Other Study ID Numbers: 4020-01-001
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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