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BRIEF TITLE: Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors

  • Org Study ID: 4040-01-001
  • Secondary ID:
  • NCT ID: NCT03250832
  • NCT Alias:
  • Sponsor: Tesaro, Inc. - Industry
  • Source: Tesaro, Inc.

Brief Summary

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.

Detailed Description

This is a multi-center, open-label, first-in-human, Phase 1 study evaluating the anti-LAG-3
antibody of TSR-033 alone and in combination with anti-PD-1. The study will be conducted in 2
parts, with Part 1 consisting of dose escalation to determine the RP2D of TSR-033 as a single
agent (Part 1a) and in combination with an anti-PD-1 antibody (Part 1c). RP2D decisions will
be based on the occurrence of dose-limiting toxicities (DLTs), PK, as well as PDy data. These
regimens will be evaluated in patients with advanced solid tumors who have limited available
treatment options as determined by the Investigator.

Part 2 of the study will evaluate the anti-tumor activity of TSR-033 in combination with an
anti-PD-1 in patients.

Overal Status Start Date Phase Study Type
Recruiting August 1, 2017 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0

Primary Outcome 1 - Time Frame: Part 1: Dose Escalation cohorts - 2 years

Primary Outcome 2 - Measure: Number of Participants with Solid Tumors With Complete or Partial Response to the Anti-Tumor Activity of TSR-033 in Combination with Anti-PD-1

Primary Outcome 2 - Time Frame: Part 2: Dose Expansion Cohorts - 2 years


  • Advanced Solid Tumors
  • Antibodies
  • Immunotherapy


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

- 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

- 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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Ying Wang, M.D., Ph.D

Role: Study Director

Affiliation: Tesaro, Inc.

Overall Contact

Name: Ying Wang, M.D., Ph.D.

Phone: 781-257-2449



Facility Status Contact
Moffitt Cancer Center
Tampa, Florida 33612
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma 73117
United States
San Antonio, Texas 78229
United States
Gustave Roussy
Villejuif, Ile-de-France 94805