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.
- 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.
- 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.
University of Alabama at Birmingham Cancer Center
Mayo Clinic in Arizona
UCLA / Jonsson Comprehensive Cancer Center
UC Irvine Health / Chao Family Comprehensive Cancer Center
University of California San Diego
UCSF Medical Center-Mount Zion
Contact: Kimberly Ann Silverio
District of Columbia
MedStar Georgetown University Hospital
Mayo Clinic in Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center
Moffitt Cancer Center
Contact: Hye Sook Chon
Emory University Hospital / Winship Cancer Institute
University of Chicago Comprehensive Cancer Center
University of Kansas Clinical Research Center
University of Kansas Cancer Center
University of Kansas Hospital-Westwood Cancer Center
Johns Hopkins University / Sidney Kimmel Cancer Center
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Massachusetts General Hospital Cancer Center
Wayne State University / Karmanos Cancer Institute
Laura and Isaac Perlmutter Cancer Center at NYU Langone
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Case Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
University of Oklahoma Health Sciences Center
OHSU Knight Cancer Institute
Fox Chase Cancer Center
University of Pennsylvania / Abramson Cancer Center
Vanderbilt University / Ingram Cancer Center
UT Southwestern / Simmons Cancer Center-Dallas
Contact: Marcella West Aguilar
Ben Taub General Hospital
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Contact: Sonia Lisa Creighton
Salt Lake City
Huntsman Cancer Institute / University of Utah
University of Virginia Cancer Center
Fred Hutch / University of Washington Cancer Consortium
Trial Phase Phase I
Trial Type Treatment
- Primary ID 4010-01-001
- Secondary IDs NCI-2016-01910, s16-01027
- Clinicaltrials.gov ID NCT02715284