Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
Condition: Metastatic Cancer; Solid Tumor; Lymphoma
MeSH terms: Lymphoma
Intervention: Sym022
Intervention description: Sym022 is a recombinant, fully human antibody that binds LAG-3 and blocks the LAG-3/major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally advanced/unresectable; Metastatic solid tumor; Lymphoma; Anti-LAG-3; LAG-3; LAG3

Summary:

      This is the first study to test Sym022 in humans. The primary purpose of this study is to see
      if Sym022 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 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 organ transplantation (e.g. stem cell or solid organ transplant)

          -  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).

          -  Other Inhibitors of LAG-3

          -  Any antineoplastic agent for the primary malignancy (standard or investigational)
             without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest,
             prior to first administration of study drug and during study

          -  Any other investigational treatments within 4 weeks prior to and during study

          -  Radiotherapy for target lesions within 4 weeks prior to first administration of study
             drug unless PD has been documented in the lesion following treatment, and during
             study.

          -  Radiotherapy for non-target lesions within 1 week prior to first administration of
             study drug

          -  Immunosuppressive or systemic hormonal therapy

          -  Prophylactic use of hematopoietic growth factors within 1 week prior to first
             administration of study drug and during Cycle 1 of study