A Study of EMD525797 in Solid Tumor Patients in Japan
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: EMD525797; EMD525797; EMD525797; EMD525797
Intervention description: Subjects will receive 250 milligram (mg) of EMD525797 intravenously every 2 weeks, until progressive disease (PD), unacceptable toxicity or withdrawal of consent.; Subjects will receive 500 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity or withdrawal of consent.; Subjects will receive 1000 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity or withdrawal of consent.; Subjects will receive 1500 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity, or withdrawal of consent.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: alpha v integrin; antibody; solid tumor; Japanese; EMD525797

Summary:

      The primary objectives are to assess the safety and tolerability of single and repeated doses
      of EMD525797, and characterize Pharmacokinetics (PK). The secondary objectives are to
      investigate the immunogenicity and Progressive disease (PD), and to assess the anti-tumor
      activity of EMD525797.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to (>=) 20 years

          -  Histologically or cytologically proven advanced or metastatic solid tumor

          -  Evidence of progressive disease after standard chemotherapy or no standard
             chemotherapy

          -  Confirmation of availability of formalin-fixed paraffin-embedded (FFPE) tumor block(s)
             or tissue sections

          -  Presence of at least one measurable lesion according to Response Evaluation Criteria
             in Solid Tumors (RECIST) Version 1.0 complete tumor assessment to be performed within
             the 30 days prior to the first EMD525797 administration

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

          -  Estimated life expectancy of at least 3 months

          -  Absolute Neutrophil Count (ANC) >= 1.5 x 10^9 per liter (/Liter)

          -  Platelets >= 100 x 10^9/Liter

          -  Haemoglobin >= 9.0 gram per deciliter (g/dL) (without transfusions)

          -  Total bilirubin less than or equal to (<=) 1.5 x upper limit of normal (ULN)

          -  Aspartate transaminase (AST), alanine transaminase (ALT) less than or equal to (<=) 3
             x ULN

          -  In subjects with hepatic metastasis, total bilirubin <= 3 x ULN, AST and ALT <= 5 x
             ULN

          -  Prothrombin time (PT), prothrombin time/international normalized ratio (PT/INR), and
             activated partial thromboplastin time (APTT) within normal limits

          -  Creatinine clearance >= 50 milliliter per minute (mL/min)

        Other protocol defined inclusion criteria could also apply

        Exclusion Criteria:

          -  Previous treatment with anti-integrin therapy

          -  Radiotherapy to bone lesions, systemic surgery, orthopedic surgery (all within the 4
             week prior to treatment with EMD525797), clinically significant unhealed wound, or
             unrecovered bone fracture

          -  Chronic doses of oral steroids, defined as >= 10 milligram of prednisone equivalents
             per day

          -  Confirmed or clinically suspected brain or leptomeningeal metastases

          -  Known hypersensitivity to EMD525797 or its excipients

          -  History of allergic reactions to other monoclonal antibody therapy

          -  Antibody treatment within the past 8 weeks or chemotherapy within the 4 weeks prior to
             treatment with EMD525797

          -  Uncontrolled diabetes

          -  Uncontrolled hypertension defined as systolic blood pressure >= 160 millimeter of
             mercury (mmHg) and/or diastolic blood pressure >= 100 millimeter of mercury (mmHg)
             under resting conditions

          -  Autoimmune diseases

          -  Current history of chronic daily acetylsalicylic acid (ASS) therapy (ASS at doses
             <=100 mg is permitted)

          -  Bleeding disorders;

          -  History of thromboembolic events (history of superficial thrombophlebitis is not an
             exclusion

          -  Anticoagulants within the past 10 days prior to the first treatment and during
             treatment period

          -  Severe peripheral vascular disease or ulceration

          -  Unstable angina pectoris, or myocardial infarction or other severe heart diseases
             within the past 6 months before treatment with EMD 525797

          -  Clinical significant abnormal ECG at screening

          -  Dementia, altered mental status, or any psychiatric condition that would prohibit the
             understanding or rendering of informed consent

          -  Known HIV infection, active or chronic carrier of hepatitis B virus (HBV antigen
             positive or HBV DNA positive) or hepatitis C virus (HCV antibody positive)

        Other protocol defined exclusion criteria could also apply