Overview
Phase 1 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR)
Status:
Completed
Completed
Trial end date:
2015-10-28
2015-10-28
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
Advanced ovarian cancer is a high medical need indication. Cure is not available to these patients and treatment has palliative intent. A proportion of advanced stage ovarian cancer expresses substantial levels of Claudin 6 (CLDN6), a carcino-embryonic transmembrane protein, which is absent from normal adult human tissue. IMAB027 is a monoclonal antibody that binds to CLDN6. Preclinically IMAB027 was shown to inhibit tumor growth and to kill cancer cells by antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. This trial is a first-in-human dose escalation and dose finding Phase 1 trial of IMAB027 in patients with recurrent advanced ovarian cancer to assess the safety and tolerability, the pharmacokinetics, the antitumoral activity and the immunogenicity of IMAB027.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Ganymed Pharmaceuticals AG
Ganymed Pharmaceuticals GmbH
Criteria
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