A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer
Condition: GI Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: AMG 211
Intervention description: continuous intravenous infusion (cIV) infusion in cycles from 7 to 28 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amgen; Phase 1; Clinical Trial; Oncology; GI adenocarcinoma; Immunotherapy

Summary:

      The purpose of this Phase 1 study is to determine if AMG 211 given as a continous intravenous
      (IV) infusion is safe and tolerable in adult participants that have advanced gastrointestinal
      adenocarcinoma. The study will be conducted in multiple sites and test increasing doses of
      AMG 211. The safety of participants will be monitored by intensive assessment of vital signs,
      electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed by
      the usual imaging procedures and their interpretation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent provided

          -  18 years or older

          -  Advanced relapsed/refracted gastrointestinal adenocarcinoma

          -  At least 1 measurable tumor lesion

          -  Tumor tissue available or is willing to undergo biopsy of a tumor lesion before the
             start of treatment

          -  Adequate hematological, renal, and liver function

          -  Body weight ≥ 45 kg

          -  Other inclusion criteria may apply

        Exclusion Criteria:

          -  Malignancy other than gastrointestinal (GI) adenocarcinoma requiring current therapy

          -  Evidence of uncontrolled systemic disease, active infection, Hepatitis B and/or C,
             human immunodeficiency virus (HIV), history of cardiac disease, history of significant
             central nervous system (CNS) disease, history of chronic autoimmune disease (with the
             exception of stable type 1 diabetes)

          -  Major surgery within 28 days of study day 1

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 28 days since ending treatment in another investigational device or drug study.
             Other investigational procedures while participating in this study are excluded.
             Exception to this criterion is the participation in the optional Imaging Study and all
             procedures related to this study.

          -  Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal
             therapy for cancer within 14 days prior to study entry and not recovered from
             treatment

          -  Unresolved toxicities from prior anti-tumor therapy

          -  Males or Females of reproductive potential, and unwilling to practice an acceptable
             method of effective birth control while on study through 30 days after receiving the
             last dose of study drug

          -  Females who are pregnant, planning to become pregnant, lactating/breastfeeding or who
             plan to breastfeed while on study through 30 days after receiving the last dose of
             study drug

          -  Other exclusion criteria may apply