Study of TSR-033 With an Anti-PD-1


This is a multicenter, open-label, first-in-human Phase 1 study evaluating TSR-033, an anti-LAG-3 Monoclonal Antibody, alone and in combination with an anti-PD-1 in Patients with Advanced Solid Tumors in a broad range of solid tumors. Patients with disease types selected for evaluation in this study are expected to derive clinical benefit with addition of an anti-PD-1. The study will be conducted in two parts: dose escalation and cohort expansion.

Study Start Date

August, 01 2017

Estimated Completion Date

May 2021


  • Drug: TSR-033
  • Drug: Anti-PD-1

Study ID

Tesaro, Inc. -- 4040-01-001



Trial ID


Study Type


Trial Phase

Phase 1

Enrollment Quota



Tesaro, Inc.

Key Inclusion Criteria Part 1:
  • Patients with advanced (unresectable) or metastatic solid tumor and have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
  • Patients must have tumor tissue available.
  • Female patients must have a negative serum or urine pregnancy test or be of non-childbearing potential.
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 and adequate organ function. Key Inclusion Criteria Part 2:
  • Patients must have not been previously treated with an anti
  • LAG
  • 3, anti
  • PD
  • 1, anti
  • PD
  • L1, or anti
  • PD
  • L2 antibody. Key Exclusion Criteria for all:
  • Known uncontrolled central nervous system metastases and
  • or carcinomatous meningitis.
  • History of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C.
  • 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 Adverse Events (AEs) and
  • or complications from major surgery prior to first dose.
  • Vaccine within 7 days of planned start of study treatment.
  • Gender



    18 Years and older

    Accepts Healthy Volunteers


    Study Locations and Contact Information (4)

    Study Location Distance Name Phone Email
    Dana Farber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
    Moffitt Cancer Center - Tampa, Florida 1,178.7 miles None None None
    Sarah Cannon Research Institute - Oklahoma City, Oklahoma 1,491.9 miles None None None
    START - San Antonio, Texas 1,768.2 miles None None None provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.