Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
Condition: Metastatic Cancer; Solid Tumor; Lymphoma
MeSH terms: Lymphoma
Intervention: Sym023
Intervention description: Sym023 is a recombinant, fully human antibody that binds TIM-3 and induces activation of immune cells.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally advanced/unresectable; Metastatic solid tumor; Lymphoma; Anti-TIM-3; TIM-3; TIM3

Summary:

      This was the first study to test Sym023 in humans. The primary purpose of this study was to
      see if Sym023 is safe and tolerable for patients with locally advanced/unresectable or
      metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or
      for which no standard therapy is available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, ≥ 18 years of age at the time of obtaining informed consent.

          -  Documented (histologically- or cytologically-proven) solid tumor malignancy that is
             locally advanced or metastatic; patients with documented lymphomas.

          -  Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical
             intervention due to either medical contraindications or nonresectability of the tumor.

          -  Refractory to or intolerant of existing therapy(ies) known to provide clinical
             benefit.

          -  Measurable or non-measurable disease according to RECIST v1.1 or RECIL 2017.

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

          -  Not of childbearing potential or who agree to use a highly effective method of
             contraception during the study beginning within 2 weeks prior to the first dose and
             continuing until 6 months after the last dose of study drug.

        Exclusion Criteria:

          -  Women who are pregnant or lactating, or intending to become pregnant before, during,
             or within 6 months after the last dose of study drug. Women of childbearing potential
             (WOCBP) and fertile men with WOCBP-partner(s) not using and not willing to use a
             highly effective method of contraception.

          -  Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal
             cord compression, patients with any of the above not controlled by prior surgery or
             radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment
             is required.

          -  Hematologic malignancies other than lymphomas.

          -  Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism
             (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and
             considered stable.

          -  Active uncontrolled bleeding or a known bleeding diathesis.

          -  Clinically significant cardiovascular disease or condition.

          -  Significant ocular disease or condition, including history of autoimmune or
             inflammatory disorder.

          -  Significant pulmonary disease or condition.

          -  Current or recent (within 6 months) significant gastrointestinal (GI) disease or
             condition.

          -  An active, known, or suspected autoimmune disease, or a documented history of
             autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive
             medications.

          -  History of significant toxicities associated with previous administration of immune
             checkpoint inhibitors that necessitated permanent discontinuation of that therapy.

          -  Patients with unresolved > Grade 1 toxicity associated with any prior antineoplastic
             therapy, with exceptions.

          -  Inadequate recovery from any prior surgical procedure, or having undergone any major
             surgical procedure within 4 weeks prior to C1/D1.

          -  Known history of human immunodeficiency virus (HIV) or known active infection with
             hepatitis B virus (HBV) or hepatitis C virus (HCV).