Phase 1 trial of IMAB027 in patients with recurrent advanced ovarian cancer (OVAR)

Inclusion Criteria:

(1) Signed written informed consent

(2) Female patients ≥18 years of age, no upper age limit

(3) Histologically or cytologically confirmed CLDN6+ ovarian cancer of

any histology type including primary peritoneal or fallopian tube tumors

(histological documentation of the original primary tumor is required via

a pathology report)

(4) Performance status ECOG 0-2

(5) Patients with measurable, non-measurable, or evaluable disease: Evaluable disease: defined as a confirmed CA-125 ≥2 x ULN, Measurable disease (RECIST 1.1): defined as at least one lesion that can be accurately measured in at least one dimension

(6) Availability of a FFPE tumor tissue sample or tumor cell positive paracentesis fluid samples (abdominal or pleural cavity) for the assessment of CLDN6 positivity

(7) Life expectancy of >12 weeks

(8) Adequate organ function defined as:

Adequate hematologic function (ANC ≥1000/μl, platelets ≥100.000/μl, hemoglobin ≥9.0 g/dl (can be post transfusion)); Adequate renal function (serum creatinine ≤1.5 mg/dl [114.5 μmol/l] or creatinine clearance rate ≥30 ml/min); Adequate liver function (serum total bilirubin ≤2 x ULN, AST/ALT ≤3 x ULN)

(9) Patients of child-bearing potential must have a negative β-HCG urine

test within 72 hours before receiving treatment

Exclusion Criteria:

(1) Patient is pregnant or breast-feeding

(2) Prior allergic reaction or intolerance to a monoclonal antibody

(humanized or chimeric)

(3) Any prior anti-tumor therapy within 14 days prior to the start of

IMAB027 treatment

(4) Other concurrent anticancer therapies

(5) HIV infection in medical history or active Hepatitis B or C infection

requiring treatment

(6) History of any one or more of the following cardiovascular conditions

within the past 6 months:

Myocardial infarction (T-Wave/Non-T-Wave), Unstable angina pectoris

Class II, III or IV congestive heart failure as defined by the New

York Heart Association (NYHA), History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT). Patients with recent DVT who have been or are treated with therapeutic anti-coagulant agents (excluding warfarin) for at least 6 weeks are eligible

(7) Other investigational agents or devices concurrently or within 14 days

before start of IMAB027 treatment

(8) Any hemoptysis or bleeding event that is clinically relevant within 2 weeks of first dose of study drug

(9) Clinical symptoms of brain metastases or tumor-associated spinal cord

compression

(10) Need for continuous, systemic immunosuppressive therapy

(11) Any other medical condition that would, in the opinion of the

Investigator, limit the patient's ability to complete the study