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

Description

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

Interventions

  • Drug: TSR-033
  • Drug: Anti-PD-1

Study ID

Tesaro, Inc. -- 4040-01-001

Status

Recruiting

Trial ID

NCT03250832

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

260

Sponsor

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

    All

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    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

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