Clinical Trial - NCT02715284

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Recruiting

Sponsor: Tesaro, Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02715284

Protocol Info

Short Description: Phase 1 TSR-042 in Solid Tumors
Long Description: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors
MGH Status: Open
Sponsor: Tesaro
Disease Program: Phase I

Next Steps


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Purpose

This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody TSR-042 in patients with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts: dose escalation and cohort expansion. The cohort expansion may include various tumor types, including endometrial, Non-Small Cell Lung cancer, and MSI-H solid tumors.
Condition Title Intervention Phase
Advanced or Metastatic Solid Tumors TSR-042 Phase 1
Study Type Interventional
Official Title A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Primary Outcome Measures

To evaluate the safety and tolerability of TSR-042 in patients with advanced solid tumors and determine the recommended Phase 2 dose (RP2D) and schedule [Time Frame: Part 1 and Part 2A Dose Escalation - Approximately 12 months] [Designated as safety issue: ]

To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) and duration of response (DOR) [Time Frame: Part 2 Expansion - Approximately 12 months] [Designated as safety issue: ]


Secondary Outcome Measures

To evaluate the immunogenicity of TSR-042 [Time Frame: Part 2 - Approximately 12 months] [Designated as safety issue: ]

To determine the pharmacokinetic profile of TSR-042 [Time Frame: Part 2 - Approximately 24 months] [Designated as safety issue: ]

Immune-related disease control rate (irDCR), duration of response (irDOR) and overall response rate (irORR) based on Investigators' assessment using irRECIST [Time Frame: Part 2 - Approximately 24 months] [Designated as safety issue: ]

Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST [Time Frame: Part 2 - Approximately 24 months] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: Part 2 - Approximately 24 months] [Designated as safety issue: ]

Patient reported outcome (European Quality of Life scale, 5-Dimensions (EQ-5D-5L) [Time Frame: Part 2 - Approximately 24 months] [Designated as safety issue: ]

Patient reported outcome (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)) [Time Frame: Part 2 - Approximately 24 months] [Designated as safety issue: ]

Estimated Enrollment: 540
Study Start Date: March 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: February 2020
Arms Assigned Interventions

Experimental:Part 1 - Dose Escalation

Part 1 - Dose Escalation Part 2 of the study will be conducted in two subparts: In Part 2A, safety and tolerability of TSR-042 at fixed dose will be evaluated. In Part 2B, clinical activity of TSR-042 will be evaluated.
Biological:TSR-042
TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Patient is at least 18 years of age
  • Patient with advanced or metastatic solid tumor and has disease progression after treatment who are intolerant to treatment that meets the following requirements for the part of the study they will participate in:

1. Part 1: Patient with any advanced or metastatic solid tumor

2. Part 2A: Patient with any advanced or metastatic solid tumor

3. Part 2B: Patient with Non-Small Cell Lung Cancer (NSCLC), Endometrial cancers, and MSI-H solid tumors.

  • Female patients, if of childbearing potential, must have a negative serum pregnancy test within 72 hours prior to the date of the first dose of study medication.
  • Female patients of childbearing potential must agree to use 2 adequate methods of contraception with their partner starting with the screening visit through 150 days after the last dose of study therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 for Part 1 and ≤ 1 for Part 2. Adequate organ function.

Exclusion Criteria:

  • Patient has received prior therapy with an anti- programmed death receptor 1 (anti-PD-1), anti-PD-1- ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD- L2) agent.
  • Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are clinically stable off steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.
  • Known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell cancer (SqCC) of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
  • Known active hepatitis B (eg, hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid (HCV RNA) (qualitative) is detected).
  • Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease- modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • History of interstitial lung disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02715284

Locations

  • United States, Alabama
    • Birmingham, Alabama, United States,
  • United States, Arizona
    • Goodyear, Arizona, United States,
    • Phoenix, Arizona, United States,
    • Scottsdale, Arizona, United States,
  • United States, Arkansas
    • Fayetteville, Arkansas, United States,
  • United States, California
    • Encinitas, California, United States,
    • La Jolla, California, United States,
    • Los Angeles, California, United States,
    • Newport Beach, California, United States,
    • Orange, California, United States,
    • San Francisco, California, United States,
    • Santa Monica, California, United States,
  • United States, District of Columbia
    • Washington, District of Columbia, United States,
  • United States, Florida
    • Jacksonville, Florida, United States,
    • Miami, Florida, United States,
    • Tampa, Florida, United States,
  • United States, Georgia
    • Atlanta, Georgia, United States,
    • Augusta, Georgia, United States,
  • United States, Illinois
    • Chicago, Illinois, United States,
  • United States, Kansas
    • Westwood, Kansas, United States,
  • United States, Maine
    • Scarborough, Maine, United States,
  • United States, Maryland
    • Baltimore, Maryland, United States,
  • United States, Massachusetts
    • Boston, Massachusetts, United States,
  • United States, Michigan
    • Detroit, Michigan, United States,
  • United States, Minnesota
    • Rochester, Minnesota, United States,
  • United States, Missouri
    • Kansas City, Missouri, United States,
  • United States, New Mexico
    • Farmington, New Mexico, United States,
  • United States, New York
    • Albany, New York, United States,
    • Brooklyn, New York, United States,
    • Jamaica, New York, United States,
    • New York, New York, United States,
  • United States, North Carolina
    • Charlotte, North Carolina, United States,
  • United States, Ohio
    • Cleveland, Ohio, United States,
    • Columbus, Ohio, United States,
  • United States, Oklahoma
    • Oklahoma City, Oklahoma, United States,
  • United States, Oregon
    • Portland, Oregon, United States,
  • United States, Pennsylvania
    • Philadelphia, Pennsylvania, United States,
  • United States, Rhode Island
    • Providence, Rhode Island, United States,
  • United States, Tennessee
    • Nashville, Tennessee, United States,
  • United States, Texas
    • Dallas, Texas, United States,
    • Houston, Texas, United States,
    • San Antonio, Texas, United States,
  • United States, Utah
    • Salt Lake City, Utah, United States,
  • United States, Virginia
    • Charlottesville, Virginia, United States,
  • United States, Washington
    • Seattle, Washington, United States,
    • Spokane, Washington, United States,
  • United States, West Virginia
    • Morgantown, West Virginia, United States,
  • United States, Wisconsin
    • Milwaukee, Wisconsin, United States,
  • Canada, Alberta
    • Calgary, Alberta, Canada,
    • Edmonton, Alberta, Canada,
  • Canada, British Columbia
    • Kelowna, British Columbia, Canada,
    • Vancouver, British Columbia, Canada,
  • Canada, Ontario
    • Hamilton, Ontario, Canada,
    • London, Ontario, Canada,
  • Canada, Quebec
    • Montréal, Quebec, Canada,
  • Czechia,
    • Horovice, , Czechia,
    • Zlín, , Czechia,
  • Denmark,
    • Copenhagen, , Denmark,
    • Odense, , Denmark,
  • France, Nord Pas-De-Calais
    • Lille, Nord Pas-De-Calais, France,
  • France,
    • Caen, , France,
    • Marseille, , France,
    • Paris, , France,
    • Saint-Herblain, , France,
    • Villejuif, , France,
  • Italy,
    • Milano, , Italy,
    • Modena, , Italy,
    • Napoli, , Italy,
    • Parma, , Italy,
    • Roma, , Italy,
    • Verona, , Italy,
  • Poland,
    • Gdynia, , Poland,
    • Lublin, , Poland,
    • Olsztyn, , Poland,
    • Toruń, , Poland,
  • Spain,
    • Barcelona, , Spain,
    • Girona, , Spain,
    • Madrid, , Spain,
    • Málaga, , Spain,
    • Pamplona, , Spain,
    • Santiago De Compostela, , Spain,
    • Sevilla, , Spain,
    • Valencia, , Spain,
    • Zaragoza, , Spain,
  • United Kingdom,
    • Aberdeen, , United Kingdom,
    • London, , United Kingdom,
    • Manchester, , United Kingdom,
    • Newcastle Upon Tyne, , United Kingdom,
    • Oxford, , United Kingdom,

Sponsors and Collaborators

Tesaro, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02715284
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Tesaro, Inc.:

Metastatic solid tumors

Advanced solid tumors

anti-PD-1

TSR-042

Immunotherapy

PD-1

Endometrial

Non-small cell lung cancer, NSCLC

MSI-High

Additional relevant MeSH terms:

Neoplasms

Antibodies

Antibodies, Monoclonal

Antineoplastic Agents, Immunological

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on July 18, 2019