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

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ClinicalTrials.gov Identifier: NCT03250832
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Antibodies Immunotherapy Drug: TSR-033 Drug: Anti-PD-1 Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: Experimental: Part 1 - Dose Escalation
Part 1 will be a dose escalation to determine the RP2D of TSR-033 as a single agent and in combination with an anti-PD-1.
Drug: TSR-033
TSR-033 is a humanized monoclonal antibody (IgG4)
Other Name: LAG-3

Experimental: Experimental: Part 2 - Expansion Cohorts
Part 2 of the study will further explore the safety and clinical activity of TSR-033 in combination with anti-PD-1 in patients with select tumor types
Drug: TSR-033
TSR-033 is a humanized monoclonal antibody (IgG4)
Other Name: LAG-3

Drug: Anti-PD-1
PD-1 is an IgG4 antibody
Other Name: PD-1




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Part 1: Dose Escalation cohorts - 2 years ]
  2. 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 [ Time Frame: Part 2: Dose Expansion Cohorts - 2 years ]

Secondary Outcome Measures :
  1. PK parameter [ Time Frame: Approximately 2 years ]
    PK: AUC of TSR-033 when given alone and in combination with Anti-PD-1

  2. - Duration of response (DOR) by RECIST v. 1.1 [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  3. - Disease control rate (DCR) by RECIST v. 1.1 [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  4. - Progression-free survival (PFS) by RECIST v. 1.1 [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]
  5. - Overall survival (OS) [ Time Frame: Part 1 and Part 2 - Approximately 4 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03250832


Contacts
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Contact: Ying Wang, M.D., Ph.D. 781-257-2449 clinicaltrialstsr033@tesarobio.com

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73117
United States, Texas
START Recruiting
San Antonio, Texas, United States, 78229
France
Gustave Roussy Recruiting
Villejuif, Ile-de-France, France, 94805
Sponsors and Collaborators
Tesaro, Inc.
Investigators
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Study Director: Ying Wang, M.D., Ph.D Tesaro, Inc.

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Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT03250832     History of Changes
Other Study ID Numbers: 4040-01-001
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tesaro, Inc.:
advanced solid tumors
endometrioid ovarian cancer
fallopian tube cancer
primary peritoneal cancer
breast cancer
bladder cancer
urothelial carcinoma
TNBC
triple-negative breast cancer
LAG-3

Additional relevant MeSH terms:
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Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs