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Neoplasms, Glandular and EpithelialPhase 1NCT00481936

Study of the Safety of VB6-845 in Patients With Advanced Solid Tumours of Epithelial Origin

A Phase 1 study testing VB6-845 in people with Neoplasms, Glandular and Epithelial, run by Sesen Bio, Inc. at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion to patients with advanced solid tumour of epithelial origin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Glandular and Epithelial
What is being tested?
VB6-845
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesin 2 countries
Study dates
May 2007to Apr 2008
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease Characteristics:
  • The patient must have locally advanced and/or metastatic solid tumour of epithelial origin for which standard therapy has failed or does not exist;
  • The patient must have immunohistochemically-confirmed EpCAM positive disease;
  • Patient Characteristics:
  • The patient must be male or female 18 years of age or older;
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and life expectancy ≥ 12 weeks
Show all 11Show fewer
  • The patient must have adequate organ function, as defined by the protocol
  • Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the first dose of the study drug;
  • Other:
  • The patient must be able to understand and willing to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
  • The patient must be willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study procedures

Who cannot join

  • The patient has had treatment with any investigational agent within 4 weeks, or treatment with radiation therapy to a visceral organ, immunotherapy, biological therapy, or chemotherapy within 2 weeks prior to the first dose of study medication
  • The patient has not adequately recovered from the toxic effects of previous therapy, except treatment-related anemia otherwise meeting the inclusion requirements stated above in inclusion number 5 or alopecia;
  • The patient has known clinically significant brain metastases or leptomeningeal disease (baseline computed tomography [CT] or magnetic resonance imaging [MRI] of the brain is only required if there is clinical suspicion of central nervous system involvement);
  • The patient has experienced a previous significant hypersensitivity reaction;
  • The patient has known acquired immune deficiency disease or has active hepatitis virus C (HVC) or active hepatitis virus B (HVB);
  • The patient is pregnant or breast feeding; female patients will be required to be surgically sterile, agree to use double barrier contraception, or commit to abstinence during the period of therapy; male patients will be required to be surgically sterile, use double barrier contraception, or commit to abstinence during the period of therapy
  • The patient has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Russia5 sites

  • Blokhin Cancer Research Centre, Department of Chemotherapy and Combined therapy

    Moscow

  • Blokhin Cancer Research Centre, Department of Clinical Pharmacology and Chemotherapy

    Moscow

  • Moscow City Oncology Hospital #62

    Moscow

  • Non state Institution of Ministry of Health "Central Clinical Hospital #2 named after N.A. Semashko" of Open-joint stock company "Russian Railways"

    Moscow

  • Yaroslavl Regional Clinical Oncology Hospital

    Yaroslavl

Other trials in Russia

Georgia1 site

  • Chemotherapy and Immunotherapy clinic Medulla

    Tbilisi

Other trials in Georgia

About this study

Official title: A Phase I, Escalating Dose Study of VB6-845, a Recombinant Fusion Protein Targeting EpCAM, in Patients With Advanced Solid Tumours of Epithelial Origin

The purpose of this study is to determine the maximum tolerated dose (MTD) of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion to patients with advanced solid tumour of epithelial origin.

Read the detailed description

The primary study objective of this Phase 1 trial was to determine the maximum tolerated dose (MTD) of VB6-845 and evaluate the safety and tolerability of VB6-845 when administered as a monotherapy intravenous (IV) infusion (over 3 hours), once weekly in 4-week cycles, to subjects with EpCAM positive advanced solid tumours of epithelial origin.

Secondary objectives included evaluating the pharmacokinetic profile and immunogenicity of VB6-845 and assessing exploratory efficacy of VB6-845.

Dose cohorts of 3-6 subjects with EpCAM positive advanced solid tumours of epithelial origin are to be entered into the study. The starting dose is defined as 1.00 mg/kg, which is 1/10 of the no observed adverse effect level (NOAEL) reached in preclinical studies. Doses are to be escalated according to the modified Fibonacci design until 2 out of 3 or 2 out of 6 subjects experienced a Dose Limiting Toxicity (DLT). The MTD is to be reached when <2 out of 6 subjects experienced a DLT. An additional 12 subjects are to be enrolled at the MTD for further characterization of VB6-845 at that level.

Regardless of dose cohort, subjects are to continue to receive treatment until an unacceptable toxicity occurred, all lesions completely disappeared or disease progression is determined.

Being tested
VB6-845
Keywords
Neoplasms, Neoplasm, Epithelial, Neoplasm, Glandular
Medical subject headings
Neoplasms, Glandular and Epithelial, Neoplasms

What participants receive

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

  • VB6-845Drug

    Intravenous infusion once weekly for 4 weeks

Study groups in NCT00481936
Study groupRoleWhat they receive
Dose EscalatingExperimentalPatients will be treated with VB6-845 as a monotherapy IV infusion, once weekly in 4-week cycles. Patients will continue to receive treatment up until the treatment stopping criteria or patient withdrawal criteria are met. Dose escalation will begin at a dose level of 1.00 mg/kg. Doses will be escalated according to the modified Fibonacci design with dose multipliers of 2.00, 1.67, 1.50, 1.40, and 1.33.
Receives: Drug: VB6-845

What is being measured

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

  1. To determine the maximum tolerated dose of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion

    Measured: 4 weeks

Secondary outcomes (1)

  1. To evaluate the pharmacokinetics, immunogenicity and exploratory efficacy of VB6-845

    Measured: 4 weeks

Timeline

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

  1. First posted4 Jun 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Why it stopped: Corporate reasons unrelated to safety and efficacy

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00481936
Sponsor's protocol ID
VB6-845-01-I
Status last verified
Mar 2023
First submitted
31 May 2007
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VB6-845 in people with Neoplasms, Glandular and Epithelial, run by Sesen Bio, Inc. at 6 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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Russia, Georgia. 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 was stopped early (reason given: Corporate reasons unrelated to safety and efficacy). Results are not available in the source record.

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?

To determine the maximum tolerated dose of VB6-845 and to evaluate the safety and tolerability of VB6-845 when administered as a monotherapy IV infusion (time frame: 4 weeks). 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 NCT00481936.

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 23 Mar 2023.

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