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Phase 1 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR) (OVAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02054351
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : November 10, 2021
Information provided by (Responsible Party):
Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH )

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: IMAB027 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-human Dose Escalation and Dose Finding Phase 1 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR)
Actual Study Start Date : February 6, 2014
Actual Primary Completion Date : October 28, 2015
Actual Study Completion Date : October 28, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: IMAB027 administration
Monotherapy - different dose Levels.
Drug: IMAB027
Stage 1 (Intrapatient dose escalation): The starting dose is set to 1 mg/m2, followed by 10 mg/m2, 30 mg/m2 and 100 mg/m2 Stage 2 (Interpatient dose escalation): 4 dose level 100 mg/m2, 300 mg/m2, 600 mg/m2, 1000 mg/m2 Extension period: 4 dose level 100 mg/m2, 300 mg/m2, 600 mg/m2, 1000 mg/m2
Other Name: ASP1650

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 24 month ]
    Safety profile including type, frequency, severity, relationship of adverse events to investigational medicinal product, dose limiting toxicities, maximum tolerated dose

Secondary Outcome Measures :
  1. to assess pharmacokinetics [ Time Frame: 24 month ]
    Cmax, AUC, terminal half-life and related pharmacokinetic parameters of IMAB027

  2. to assess antitumoral activity [ Time Frame: up to 3 years ]
    Disease control rates (CR, PR, SD), ratio previous/current remission time intervals and overall survival

  3. to assess immunogenicity [ Time Frame: 24 month ]
    Frequency of anti-IMAB027 antibodies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02054351

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UZ Brussels
Brussels, Belgium, 1090
UZ Leuven
Leuven, Belgium, 3000
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Universitäts-Frauenklinik (UFK) Tübingen
Tübingen, Baden-Württemberg, Germany, 72076
Universitätsklinikum Ulm, Frauenklinik
Ulm, Baden-Württemberg, Germany, 89075
Universitätsmedizin Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, Sachsen, Germany, 1307
Kiel, Schleswig-Holstein, Germany, 24105
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Ganymed Pharmaceuticals GmbH
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Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
Additional Information:
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Responsible Party: Ganymed Pharmaceuticals GmbH Identifier: NCT02054351    
Other Study ID Numbers: GM-IMAB-002-01
2013-002755-15 ( EudraCT Number )
1650-CL-0101 ( Other Identifier: Astellas Pharma Global Development, Inc. )
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH ):
Advanced ovarian cancer
CLDN6 positive
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type