Skip to main content

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

Trial Status: Active

This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as 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 non-endometrial deficient mismatch repair (dMMR) / microsatellite instability-high (MSI-H) solid tumors.

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:
  • Part 1: Patient with any advanced or metastatic solid tumor
  • Part 2A: Patient with any advanced or metastatic solid tumor
  • 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.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
San Diego
University of California San Diego
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Kimberly Ann Silverio
Phone: 415-514-6725

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: CLOSED_TO_ACCRUAL
Tampa
Moffitt Cancer Center
Status: COMPLETED
Contact: Hye Sook Chon
Phone: 813-745-7205

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Kansas

Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: APPROVED
Brigham and Women's Hospital
Status: APPROVED
Dana-Farber Cancer Institute
Status: APPROVED
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic
Status: CLOSED_TO_ACCRUAL

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: COMPLETED

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
Ben Taub General Hospital
Status: CLOSED_TO_ACCRUAL
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Sonia Lisa Creighton
Phone: 210-450-1366

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Tesaro Inc

  • Primary ID 4010-01-001
  • Secondary IDs NCI-2016-01910, s16-01027
  • Clinicaltrials.gov ID NCT02715284