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Ovarian CancerPhase 1OVARNCT02054351

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

A Phase 1 study testing IMAB027 in people with Ovarian Cancer, run by Ganymed Pharmaceuticals GmbH at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
IMAB027
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
9 sitesin 2 countries
Study dates
6 Feb 2014to 28 Oct 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Germany7 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, Saxony, 1307

  • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • UKSH Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitäts-Frauenklinik (UFK) Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Ulm, Frauenklinik

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Belgium2 sites

  • UZ Brussels

    Brussels, 1090

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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

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.

Conditions
Ovarian Cancer
Being tested
IMAB027
Keywords
Advanced ovarian cancer, CLDN6 positive
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMAB027Drug

    Also called ASP1650

    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

Study groups in NCT02054351
Study groupRoleWhat they receive
IMAB027 administrationExperimentalMonotherapy - different dose Levels.
Receives: Drug: IMAB027

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

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

    Measured: 24 month

Secondary outcomes (3)

  1. to assess pharmacokinetics

    Cmax, AUC, terminal half-life and related pharmacokinetic parameters of IMAB027

    Measured: 24 month

  2. to assess antitumoral activity

    Disease control rates (CR, PR, SD), ratio previous/current remission time intervals and overall survival

    Measured: up to 3 years

  3. to assess immunogenicity

    Frequency of anti-IMAB027 antibodies

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2014 (estimated)
  2. Study start6 Feb 2014
  3. Primary completion28 Oct 2015
  4. Study completion28 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02054351
Sponsor's protocol ID
GM-IMAB-002-01
Other IDs
2013-002755-15, 1650-CL-0101
Acronym
OVAR
Status last verified
Nov 2024
First submitted
29 Jan 2014
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: 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/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMAB027 in people with Ovarian Cancer, run by Ganymed Pharmaceuticals GmbH at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02054351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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