Study of IMC-11F8 in Participants With Advanced Solid Tumors
Condition: Neoplasms
Intervention: IMC-11F8; IMC-11F8; IMC-11F8
Intervention description: 600 milligrams (mg) intravenously, Days 1 and 8 every 3 weeks; 800 mg intravenously, every 2 weeks; 800 mg intravenously, Days 1 and 8 every 3 weeks
Intervention MeSH terms: Necitumumab; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Human Immunoglobulin Gamma-1 (IgG1); Monoclonal Antibody (MAb); Epidermal Growth Factor Receptor (EGFR); Advanced Solid Tumors

Summary:

      This study is to establish the safety and pharmacokinetic (PK) profile of IMC-11F8,
      administered either: (1) in a 3-week cycle; or (2) in a 2-week cycle to Japanese participants
      with advanced solid tumors who have not responded to standard therapy or for whom no standard
      therapy is available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Solid tumor participant who has been histopathologically or cytologically documented

          -  Advanced primary or recurrent solid tumors participant who has not responded to
             standard therapy or for whom no standard therapy is available

          -  The participant has measurable or nonmeasurable lesions according to Response
             Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 guidelines

          -  The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS)
             score of 0 or 1 at study entry

          -  The participant is able to provide written informed consent

          -  The participant is age 20 years or older

          -  The participant has a life expectancy of > 3 months

          -  The participant has adequate hematologic function

          -  The participant has adequate renal function

          -  The participant agrees to use adequate contraception for the duration of study
             participation and for at least 12 weeks after the last dose of study therapy

          -  The participant has adequate recovery from recent surgery, chemotherapy, and radiation
             therapy (including palliative radiation therapy). At least 28 days (6 weeks for
             nitrosoureas or mitomycin C) must have elapsed from major surgery, prior chemotherapy,
             prior treatment with an investigational agent or device, or prior radiation therapy.
             For treatment with nonapproved monoclonal antibodies, a minimum of 8 weeks must have
             elapsed

          -  The participant is willing to comply with study procedures until the End-of-Therapy
             visit

        Exclusion Criteria:

          -  The participant has received chemotherapy or therapeutic radiotherapy within 28 days
             (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or the
             participant has ongoing side effects ≥Grade 2 due to agents administered more than 28
             days earlier (except alopecia)

          -  The participant has documented and/or symptomatic brain or leptomeningeal metastases
             (participants who are clinically stable [no symptoms during the 4 weeks prior to
             enrollment] with an assessment that no further treatment [radiation, surgical
             excision, or administration of steroids] is required are permitted to enter the study)

          -  The participant has an uncontrolled intercurrent illness including, but not limited
             to:

               -  Ongoing or active infection requiring systemic antibiotic treatment

               -  Congestive heart failure (Class III or IV per the New York Heart Association
                  heart disease classification guidelines)

          -  The participant has participated in clinical studies of nonapproved experimental
             agents or procedures within 4 weeks prior to first dose of study therapy, or within 8
             weeks prior to first dose of study therapy for nonapproved monoclonal antibodies

          -  The participant has received any previous treatment with monoclonal antibodies
             targeting the epidermal growth factor receptor (EGFR). Previous treatment with EGFR
             tyrosine kinase inhibitors (TKI), approved or nonapproved, is allowed. There must be a
             time interval of at least 4 weeks between the last EGFR TKI dose and the first dose of
             IMC-11F8

          -  The participant has acute or subacute intestinal occlusion/obstruction

          -  The participant has a history of inflammatory bowel disease (for example, Crohn's
             disease, ulcerative colitis) requiring medical intervention in the 3 years prior to
             study entry

          -  The participant has acute pulmonary disorder, interstitial pneumonia, pulmonary
             fibrosis, or history thereof

          -  The participant has a known allergy to any of the treatment components, or to
             monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human
             serum albumin, cytokines, or interleukins. In the event that there is suspicion that
             the participant may have allergies, the participant should be excluded

          -  The participant, if female, is pregnant (confirmed by urine or serum pregnancy test)
             or lactating

          -  The participant has known alcohol or drug dependency

          -  The participant is hepatitis B virus (HBV) antigen, hepatitis C virus (HCV) antibody,
             or human immunodeficiency virus (HIV) antibody positive

          -  The participant is assessed as inadequate for the study by the investigator