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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH )
ClinicalTrials.gov Identifier:
NCT02054351
First received: January 29, 2014
Last updated: June 30, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Ovarian Cancer Drug: IMAB027 Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH ):

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

  • 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

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


Enrollment: 72
Study Start Date: December 2013
Study Completion Date: March 21, 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054351

Locations
Belgium
UZ Brussels
Brussels, Belgium, 1090
UZ Leuven
Leuven, Belgium, 3000
Germany
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
UKSH Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Ganymed Pharmaceuticals GmbH
Investigators
Principal Investigator: Dirk Jaeger, Prof. Dr. Nationales Zentrum für Tumorerkrankungen, Heidelberg
  More Information

Responsible Party: Ganymed Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT02054351     History of Changes
Other Study ID Numbers: GM-IMAB-002-01
2013-002755-15 ( EudraCT Number )
Study First Received: January 29, 2014
Last Updated: June 30, 2017

Keywords provided by Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH ):
Advanced ovarian cancer
CLDN6 positive

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 18, 2017