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

Status: Active

Description

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.

Eligibility Criteria

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 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
  • Patients with radiologic or clinical progression ≤ 8 weeks after initiation of a prior anti-PD-1 or anti-PD-L1 antibody (Cohort 2D)
  • Patients with known EGFR mutation, ALK translocation or ROS1 mutation (Cohort 2D)

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Active
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Temporarily closed to accrual
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Approved
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

New York

Bronx
Montefiore Medical Center-Einstein Campus
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Temporarily closed to accrual
Name Not Available

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Tesaro Inc

Trial IDs

Primary ID 4020-01-001
Secondary IDs NCI-2016-01254
Clinicaltrials.gov ID NCT02817633