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Phase 1/2 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ganymed Pharmaceuticals AG
Sponsor:
Information provided by (Responsible Party):
Ganymed Pharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT02054351
First received: January 29, 2014
Last updated: June 24, 2014
Last verified: February 2014
  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 1/2 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.


Condition Intervention Phase
Ovarian Cancer
Drug: IMAB027
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A First-in-human Dose Escalation and Dose Finding Phase 1/2 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR)

Resource links provided by NLM:


Further study details as provided by Ganymed Pharmaceuticals AG:

Primary Outcome Measures:
  • Phase 1: Frequency, severity, duration, type of adverse events [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • Phase 2: Disease control rate according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 [ Time Frame: up to 32 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase 1: Disease Control Rate according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1 [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Phase 2: Frequency, severity, duration, type of adverse events [ Time Frame: up to 32 months ] [ Designated as safety issue: Yes ]
  • Phase 2: Progression free survival, Objective response rate, Overall survival [ Time Frame: up to 32 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMAB027 administration Drug: IMAB027

Phase 1

  • Intrapatient dose escalation: 1 mg/m2, 10 mg/m2, 30 mg/m2, 100 mg/m2
  • Interpatient dose escalation: 100 mg/m2, 300 mg/m2, 600 mg/m2, 1000 mg/m2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 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

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

Contacts
Contact: Angelika Schönfeld QA-GCP@ganymed.ag

Locations
Belgium
UZ Brussels Recruiting
Brussels, Belgium, 1090
Contact    0032 24775459      
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Ignace Vergote, Prof. Dr.    0032 16344208    Ignace.Vergote@uzleuven.be   
Principal Investigator: Ignace Vergote, Prof. Dr.         
Germany
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Dirk Jäger, Prof. Dr.    0049 622 156 7229    dirk.jaeger@med.uni-heidelberg.de   
Principal Investigator: Dirk Jäger, Prof. Dr.         
Universitäts-Frauenklinik (UFK) Tübingen Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Sara Brucker, Prof. Dr. med.    0049 707 129 807 91    sara.brucker@med.uni-tuebingen.de   
Principal Investigator: Sara Brucker, Prof. Dr. med.         
Universitätsklinikum Ulm, Frauenklinik Recruiting
Ulm, Baden-Württemberg, Germany, 89075
Contact: Jens Huober, Dr. med.    0049 731 500 58511    jens.huober@uniklinik-ulm.de   
Principal Investigator: Jens Huober, Dr. med.         
Onkologische Schwerpunktpraxis Bielefeld Not yet recruiting
Bielefeld, Nordrhein-Westfalen, Germany, 33604
Contact: Marianne Just, Dr. med.    0049 351 144 723 40    marianne.just@onkologie-bielefeld.de   
Principal Investigator: Marianne Just, Dr. med.         
Gemeinschaftspraxis Hämatologie-Onkologie Not yet recruiting
Dresden, Sachsen, Germany, 1307
Contact: Lutz Jacobasch, Dr. med.    0049 351 144 723 40    jacobasch@onkologie-dresden.net   
Principal Investigator: Lutz Jacobasch, Dr. med.         
UKSH Kiel Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Felix Hilpert, Dr. med.    0049 431 597 2100    fhilpert@email.uni-kiel.de   
Principal Investigator: Felix Hilpert, Dr. med.         
Sub-Investigator: Madalena Schwarz, Dr. med.         
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Jalid Sehouli, Prof. Dr. med.    0049 30 450 564 002    jalid.sehouli@charite.de   
Principal Investigator: Jalid Sehouli, Prof. Dr. med.         
Sub-Investigator: Radoslav Chekerov, Dr. med.         
Sponsors and Collaborators
Ganymed Pharmaceuticals AG
Investigators
Principal Investigator: Dirk Jaeger, M.D. Nationales Zentrum für Tumorerkrankungen, Heidelberg
  More Information

No publications provided

Responsible Party: Ganymed Pharmaceuticals AG
ClinicalTrials.gov Identifier: NCT02054351     History of Changes
Other Study ID Numbers: GM-IMAB-002-01, 2013-002755-15
Study First Received: January 29, 2014
Last Updated: June 24, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Ukraine: State Expert Center of Ministry of Health of Ukraine
Russia: Federal Service on Surveillance in Healthcare and Social Development

Keywords provided by Ganymed Pharmaceuticals AG:
Advanced ovarian cancer
CLDN6 positive

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

ClinicalTrials.gov processed this record on November 23, 2014