Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005897

Trial Description

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Title

A First-in-human Dose Escalation and Dose Finding Phase 1/2 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR)

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Trial Acronym

OVAR

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URL of the Trial

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Brief Summary in Lay Language

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 1/2
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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005897
  •   2015/03/05
  •   2014/01/29
  •   no
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Secondary IDs

  •   2013-002755-15 
  •   NCT02054351  (ClinicalTrials.gov)
  •   GM-IMAB-002-01  (Ganymed Pharmaceuticals AG)
  •   2013-002755-15 
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Health Condition or Problem studied

  •   Ovarian Cancer
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Interventions/Observational Groups

  •   Drug: IMAB027
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
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Primary Outcome

- Phase 1: Frequency, severity, duration, type of adverse events; time frame: 5 months
- Phase 2: Disease control rate according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1; time frame: up to 32 months

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Secondary Outcome

- Phase 1: Disease Control Rate according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1; time frame: 5 months
- Phase 2: Frequency, severity, duration, type of adverse events; time frame: up to 32 months
- Phase 2: Progression free survival, Objective response rate, Overall survival; time frame: up to 32 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2013/12/31
  •   72
  •   Multicenter trial
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional 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 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 potential1 must have a negative β-HCG urine test within 72
hours before receiving treatment

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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.

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Addresses

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    • Ganymed Pharmaceuticals AG
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    • Nationales Zentrum für Tumorerkrankungen, Heidelberg
    • Dirk Jaeger, M.D. 
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    • Nicole Dagenbach 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.