Trial document

This study has been imported from without additional data checks.
drksid header


Trial Description

start of 1:1-Block title


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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

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

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language


end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005897
  •   2015/03/05
  •   2014/01/29
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2013-002755-15 
  •   NCT02054351  (
  •   GM-IMAB-002-01  (Ganymed Pharmaceuticals AG)
  •   2013-002755-15 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Ovarian Cancer
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: IMAB027
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   [---]*
  •   2013/12/31
  •   72
  •   Multicenter trial
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1. Patient is pregnant or breast-feeding

2. Prior allergic reaction or intolerance to a monoclonal antibody (humanized or

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

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

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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • Ganymed Pharmaceuticals AG
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Nationales Zentrum für Tumorerkrankungen, Heidelberg
    • Dirk Jaeger, M.D. 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Nicole Dagenbach 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in and DRKS are not identical. Therefore the data import from 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.