RKHO_TESARO_4020-01-001_AMBER

A Phase 1 Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors

Criteria
Partial Inclusion Criteria:

Patient with advanced or metastatic solid tumor and has disease progression or treatment intolerance after treatment with available therapies
Agreement to biopsies before and during treatment, depending on study part
Female patients must have a negative serum pregnancy test or be of non-childbearing potential.
Two methods of contraception required for males and females of childbearing potential
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 and adequate organ function
Partial Exclusion Criteria:

Received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent within 8 weeks prior to initiation of study treatment depending on study part
Known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis or known malignancy that progressed or required active treatment within the last 2 years
Pregnant, breastfeeding, or expecting to conceive children within projected duration of study
History of human immunodeficiency virus (HIV), interstitial lung disease, active Hepatitis B or Hepatitis C
Autoimmune disease that required systemic treatment
Not recovered from radiation and chemotherapy-induced AEs or received blood transfusion
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 AEs and/or complications from major surgery prior to first dose
Received a vaccine within 7 days of first dose
Phase I
NCT02817633
Cancer
Multiple Tumor Types
Ying Zhuo, M.D.
Tesaro, Inc.
Paul Alderson
  • Kadlec Clinic Hematology and Oncology
  • Kadlec Research