NCT02054351

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 ovarian-cancer

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1 ovarian-cancer

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

February 6, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2015

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

January 29, 2014

Last Update Submit

November 19, 2024

Conditions

Ovarian Cancer

Keywords

Advanced ovarian cancerCLDN6 positive

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Safety profile including type, frequency, severity, relationship of adverse events to investigational medicinal product, dose limiting toxicities, maximum tolerated dose

    24 month

Secondary Outcomes (3)

  • to assess pharmacokinetics

    24 month

  • to assess antitumoral activity

    up to 3 years

  • to assess immunogenicity

    24 month

Study Arms (1)

IMAB027 administration

EXPERIMENTAL

Monotherapy - different dose Levels.

Drug: IMAB027

Interventions

IMAB027DRUG

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

Also known as: ASP1650
IMAB027 administration

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Female patients ≥18 years of age, no upper age limit
  • 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)
  • Performance status ECOG 0-2
  • 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
  • Availability of a FFPE tumor tissue sample or tumor cell positive paracentesis fluid samples (abdominal or pleural cavity) for the assessment of CLDN6 positivity
  • Life expectancy of \>12 weeks
  • 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)
  • Patients of child-bearing potential must have a negative β-HCG urine test within 72 hours before receiving treatment

You may not qualify if:

  • Patient is pregnant or breast-feeding
  • Prior allergic reaction or intolerance to a monoclonal antibody (humanized or chimeric)
  • Any prior anti-tumor therapy within 14 days prior to the start of IMAB027 treatment
  • Other concurrent anticancer therapies
  • HIV infection in medical history or active Hepatitis B or C infection requiring treatment
  • 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
  • Other investigational agents or devices concurrently or within 14 days before start of IMAB027 treatment
  • Any hemoptysis or bleeding event that is clinically relevant within 2 weeks of first dose of study drug
  • Clinical symptoms of brain metastases or tumor-associated spinal cord compression
  • Need for continuous, systemic immunosuppressive therapy
  • Any other medical condition that would, in the opinion of the Investigator, limit the patient's ability to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UZ Brussels

Brussels, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitäts-Frauenklinik (UFK) Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitätsklinikum Ulm, Frauenklinik

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, Saxony, 1307, Germany

Location

UKSH Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Senior Medical Director

    Astellas Pharma Global Development, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 4, 2014

Study Start

February 6, 2014

Primary Completion

October 28, 2015

Study Completion

October 28, 2015

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Locations

DE(7)BE(2)