Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    02817633
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817633
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Tesaro, Inc.

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. 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: TSR-042, an anti-PD-1 antibody Drug: TSR-033, an anti-LAG-3 antibody Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 819 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 (AMBER)
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1- Dose Escalation

1a: Dose escalation TSR-022 alone {currently closed to enrollment}

1b: Dose escalation TSR-022 in combination with an anti-PD-1 antibody (nivolumab) {currently closed to enrollment}

1c: TSR-022 dose in combination with an anti-PD-1 antibody (TSR-042) {currently closed to enrollment}

1d: Dose escalation TSR-022 in combination with an anti-PD-1 antibody (TSR-042) and an anti-LAG-3 antibody (TSR-033)

1e: TSR-022 in combination with an anti-PD-1 antibody in specific tumor types who have not received prior immunotherapy

Drug: TSR-022
TSR-022 is a humanized monoclonal IgG4 antibody binds to TIM3
Other Name: TIM 3

Drug: TSR-042, an anti-PD-1 antibody
TSR-042 is a humanized monoclonal IgG4 antibody binds to PD-1
Other Name: PD-1

Drug: TSR-033, an anti-LAG-3 antibody
TSR-033 is a humanized monoclonal IgG4 antibody binds to Lag 3
Other Name: Lag3

Experimental: Part 2- Expansion Cohorts

Part 2 of the study will evaluate the anti-tumor activity of TSR-022, in combination with TSR-042 and as monotherapy as deemed necessary.

Cohort A: anti-PD-1 treated melanoma (currently closed to enrollment), Cohort B: anti-PD-1 treated NSCLC, Cohort C: (CRC) no more than 3 lines of prior therapy (currently closed to enrollment)

Drug: TSR-022
TSR-022 is a humanized monoclonal IgG4 antibody binds to TIM3
Other Name: TIM 3

Drug: TSR-042, an anti-PD-1 antibody
TSR-042 is a humanized monoclonal IgG4 antibody binds to PD-1
Other Name: PD-1




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 1e and Part 2 Expansion - Approximately 2 years ]
  3. Recommended Phase 2 dose (RP2D) and schedule as monotherapy and in combination therapy [ 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 ]
  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. Immunogenicity as assessed by the presence of anti-drug antibodies [ Time Frame: Part 1 and 2 -Approximately 4 years ]
  9. Maximum plasma concentration (Cmax) of TSR-022 [ Time Frame: Part 1 - Approximately 9 months ]
  10. Minimum plasma concentration (Cmin) of TSR-022 [ Time Frame: Part 1 - Approximately 9 months ]
  11. Area under the curve (AUC),0-infinity of TSR-022 [ Time Frame: Part 1 - Approximately 9 months ]
  12. Area under the curve at steady state (AUC,ss) of TSR-022 [ Time Frame: Part 1 - Approximately 9 months ]
  13. Maximum plasma concentration at steady state (Cmax,ss) of TSR-022 [ Time Frame: Part 1 - Approximately 9 months ]
  14. Minimum plasma concentration at steady state (Cmin,ss) of TSR-022 [ Time Frame: Part 1 - Approximately 9 months ]
  15. Maximum plasma concentration (Cmax) of TSR-042 [ Time Frame: Part 1 - Approximately 9 months ]
  16. Minimum plasma concentration (Cmin) of TSR-042 [ Time Frame: Part 1 - Approximately 9 months ]
  17. Area under the curve (AUC),0-infinity of TSR-042 [ Time Frame: Part 1 - Approximately 9 months ]
  18. Area under the curve at steady state (AUC,ss) of TSR-042 [ Time Frame: Part 1 - Approximately 9 months ]
  19. Maximum plasma concentration at steady state (Cmax,ss) of TSR-042 [ Time Frame: Part 1 - Approximately 9 months ]
  20. Minimum plasma concentration at steady state (Cmin,ss) of TSR-042 [ Time Frame: Part 1 - Approximately 9 months ]
  21. Maximum plasma concentration (Cmax) of TSR-033 [ Time Frame: Part 1 - Approximately 9 months ]
  22. Minimum plasma concentration (Cmin) of TSR-033 [ Time Frame: Part 1 - Approximately 9 months ]
  23. Area under the curve (AUC),0-infinity of TSR-033 [ Time Frame: Part 1 - Approximately 9 months ]
  24. Area under the curve at steady state (AUC,ss) of TSR-033 [ Time Frame: Part 1 - Approximately 9 months ]
  25. Maximum plasma concentration at steady state (Cmax,ss) of TSR-033 [ Time Frame: Part 1 - Approximately 9 months ]
  26. Minimum plasma concentration at steady state (Cmin,ss) of TSR-033 [ Time Frame: Part 1 - Approximately 9 months ]
  27. Maximum plasma concentration (Cmax) of nivolumab [ Time Frame: Part 1 - Approximately 9 months ]
  28. Minimum plasma concentration (Cmin) of nivolumab [ Time Frame: Part 1 - Approximately 9 months ]
  29. Area under the curve (AUC),0-infinity of nivolumab [ Time Frame: Part 1 - Approximately 9 months ]
  30. Area under the curve at steady state (AUC,ss) of nivolumab [ Time Frame: Part 1 - Approximately 9 months ]
  31. Maximum plasma concentration at steady state (Cmax,ss) of nivolumab [ Time Frame: Part 1 - Approximately 9 months ]
  32. Minimum plasma concentration at steady state (Cmin,ss) of nivolumab [ Time Frame: Part 1 - Approximately 9 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 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 with adequate hematologic and 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 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

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
Layout table for location contacts
Contact: Beth Zaharoff (781) 209-5485 bzaharoff@tesarobio.com

  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Completed
Goodyear, Arizona, United States, 85338
Recruiting
Phoenix, Arizona, United States, 85054
Recruiting
Scottsdale, Arizona, United States, 85258
Recruiting
Tucson, Arizona, United States, 85711
United States, California
Recruiting
Encinitas, California, United States, 92024
Recruiting
Fresno, California, United States, 93720
Recruiting
Los Angeles, California, United States, 90095
Recruiting
San Marcos, California, United States, 92069
Recruiting
Whittier, California, United States, 90603
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Recruiting
Jacksonville, Florida, United States, 32224
Recruiting
Miami Beach, Florida, United States, 33140
Recruiting
Sarasota, Florida, United States, 34232
Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Recruiting
Arlington Heights, Illinois, United States, 60005
Recruiting
Chicago, Illinois, United States, 60637
United States, Iowa
Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Recruiting
Wichita, Kansas, United States, 67214
United States, Maryland
Recruiting
Rockville, Maryland, United States, 20850
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Completed
Detroit, Michigan, United States, 48202
United States, Minnesota
Recruiting
Rochester, Minnesota, United States, 55905
United States, New Jersey
Recruiting
Hackensack, New Jersey, United States, 07671
United States, New Mexico
Recruiting
Farmington, New Mexico, United States, 87401
United States, New York
Recruiting
Bronx, New York, United States, 10461
Recruiting
New York, New York, United States, 10016
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45242
Recruiting
Cleveland, Ohio, United States, 44106
United States, Oregon
Recruiting
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Recruiting
Allentown, Pennsylvania, United States, 18045
Recruiting
Bethlehem, Pennsylvania, United States, 18015
Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29425
Recruiting
Greenville, South Carolina, United States, 29605
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Recruiting
Austin, Texas, United States, 78705
Recruiting
Dallas, Texas, United States, 75246
Recruiting
Fort Worth, Texas, United States, 76104
Recruiting
Houston, Texas, United States, 77030
Recruiting
McAllen, Texas, United States, 78503
Recruiting
Paris, Texas, United States, 75460
Recruiting
San Antonio, Texas, United States, 78229
Recruiting
Temple, Texas, United States, 76508
Recruiting
Tyler, Texas, United States, 75702
United States, Virginia
Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Recruiting
Kennewick, Washington, United States, 99336
Recruiting
Vancouver, Washington, United States, 98684
United States, Wisconsin
Recruiting
Madison, Wisconsin, United States, 53792
Spain
Recruiting
Madrid, Spain, 28027
Recruiting
Madrid, Spain, 28040
Recruiting
Madrid, Spain, 28050
Recruiting
Málaga, Spain, 29010
Recruiting
Pamplona, Spain, 31008
Sponsors and Collaborators
Tesaro, Inc.
Investigators
Layout table for investigator information
Study Director: Ying Wang, PhD, MD, Tesaro, Inc.

Layout table for additonal information
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: September 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tesaro, Inc.:
Antibodies
TSR-022
Advanced solid tumors
Metastatic solid tumors
Immunotherapy
PD-1
Anti-PD-1
colorectal cancer
non-small cell lung cancer
Melanoma
Anti-LAG-3
TSR-033
TSR-042
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs