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Her2/Neu Positive Advanced Solid TumorsPhase 1/2NCT01569412

Open Label, Dose Escalating Study With Ertumaxomab In Patients With HER-2/Neu Expressing Advanced Solid Tumors

A Phase 1/2 study testing Ertumaxomab in people with Her2/Neu Positive Advanced Solid Tumors, run by Krankenhaus Nordwest at 1 site in Germany.

Terminated

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

Official record
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Trial summary

Patients with HER2/neu expressing solid tumors progressing after standard therapy will be treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this trial is to find the maximum tolerated dose. Tolerability and Safety will be assessed as well as efficacy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Her2/Neu Positive Advanced Solid Tumors
What is being tested?
Ertumaxomab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteGermany
Study dates
Mar 2012to May 2016
Phase
Phase 1/2
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

  • Signed and dated informed consent form.
  • Male or female patients aged ≥ 18 years and with a life expectancy of at least 4 months.
  • Negative pregnancy test at screening (and not more than 72 hours prior to the first ertumaxomab infusion) for women of childbearing potential. Patients must agree to use adequate contraception during the study.
  • Measurable disease, defined as at least one lesion that is measurable in one dimension.
  • Solid HER2/neu positive tumors (1+/SISH positive, 2+, and 3+), histologically confirmed.
  • Patients must have disease progression during or after standard therapy and/or are no longer feasible for approved therapies.
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  • Previous therapies must be discontinued at least 2 weeks (6 weeks in case mitomycin C) prior to administration of ertumaxomab and all treatment related toxicities must have resolved or decreased to common toxicity criteria (CTC) grade 1 (with the exception of alopecia and peripheral neuropathy).
  • If patients have received HER2-targeting therapies, all HER2-targeting therapies must have been discontinued before study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
  • Adequate hematological, liver and kidney function:
  • Adequate recovery from prior systemic therapy.
  • Patients capable to understand the purposes and risks of the study, and who are willing and able to participate in the study
  • Left ventricular ejection fraction must be > 50% at echocardiography

Who cannot join

  • Patients currently being treated with medication or anticonvulsants for brain or central nervous system metastases or patients that have documented radiologic evidence of active brain or central nervous system metastases within 12 weeks of study entry.
  • Patients with a prior diagnosis of any other malignancy (unless cured by surgery or other appropriate treatments greater than 2 years before study entry). Patients with in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin may be included at any time.
  • ≥ 5 preceding chemotherapies
  • Documented acute or chronic infection or other concurrent non-malignant co morbidities that are uncontrolled, such as unstable or uncontrolled pectorial angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis or congestive heart failure (CHF, NYHA III or IV).
  • Patients with a known human immunodeficiency virus, hepatitis B or hepatitis C positive status are excluded from participation in the study
  • Any concurrent chemotherapy, radiotherapy (except for local radiation therapy for bone marrow metastasis), hormonal therapy, immunotherapy or corticoid therapy.
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  • Treatment with any investigational product within 2 weeks prior to first administration of ertumaxomab.
  • Patients with documented autoimmune diseases.
  • Known hypersensitivity to murine proteins and any other component of the drug.
  • Abnormal organ or bone marrow function as defined below (any single parameter to fulfill condition):
  • ANC < 1.5 Gpt/l (1.5x109/L, 1500/mm3)
  • Hemoglobin <9.0 g/dl
  • Platelet count < 75Gpt/l (75x109/L, 75,000/mm³)
  • AST(SGOT)/ALT(SGPT) > 3 x upper limit of normal (ULN); or: in case of metastatic liver disease AST(SGOT)/ALT(SGPT) > 5 x ULN
  • Alkaline Phospatase > 2.5 x ULN
  • Serum (total) bilirubin > 1,5 x ULN for the institution; or in case of metastatic liver disease: Serum (total) bilirubin > 3 x ULN for the institution;
  • Serum creatinine > 1.5 x ULN
  • Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator.
  • Known hypersensitivity to ertumaxomab and its analogues in general, or to any other component of the study drug formulation.
  • Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraception (see above).
  • Use of immune-suppressive agents for the past 4 weeks prior to the first administration of ertumaxomab. For regular use of systemic corticosteroids, patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 7 days prior to first treatment.
  • Unwilling or unable to follow protocol requirements.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

Other trials in Germany

About this study

Official title: Phase I/II, Open Label, Dose Escalating Study To Investigate Safety, Tolerability, And Preliminary Efficacy Of The Trifunctional Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab In Patients With HER-2/Neu Expressing (1+/SISH Positive, 2+ and 3+) Solid Tumors Progressing After Standard Therapy

Patients with HER2/neu expressing solid tumors progressing after standard therapy will be treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this trial is to find the maximum tolerated dose. Tolerability and Safety will be assessed as well as efficacy.

Read the detailed description

This is an open label phase I/II study dose escalating study to investigate safety, tolerability, and preliminary efficacy of the trifunctional anti-HER2/neu x anti-CD3 antibody ertumaxomab in patients with HER2/neu (1+/SISH positive, 2+ and 3+) expressing solid tumors progressing after standard therapy. The primary objectives of the study is to assess the safety and tolerability of ertumaxomab in order to determine the maximum tolerated dose (MTD) and to establish a recommended dose (RD) for further development.

A maximum of ten infusions will be applicated.

Patients will be seen at baseline/screening, and then weekly for infusion and safety assessment with a break of 3 weeks after the 5th dose. Radiological tumor assessment will be performed every 6 weeks. Post-study follow-up will be completed every 8 weeks for up to one year.

Being tested
Ertumaxomab

What participants receive

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

  • ErtumaxomabBiological

    trifunctional antibody, infusion i.v., increasing doses, up to 10 infusions

Study groups in NCT01569412
Study groupRoleWhat they receive
ErtumaxomabExperimentalErtumaxomab administration during two treatment cycles will follow a predefined dose escalation scheme, consisting of 5 ascending doses per cycle with each infusion lasting 3 hours.
Receives: Biological: Ertumaxomab

What is being measured

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

  1. maximum tolerated dose

    Measured: every week until end of treatment (max. 108 days)

Secondary outcomes (3)

  1. Pharmacodynamic

    Determination of HAMA, Serum levels of cytokines IL2, 6, 8, TNF-alpha, IFN-gamma, Blood cell count (immune status), Humoral immune responses (autologous anti-EpCAM / anti-Her2neu antibodies), Identification of T memory cells

    Measured: weekly until end of treatment (max. 108 days)

  2. efficacy according to RECIST and immune related response criteria (irRC)

    Measured: every 6 weeks until progression of disease

  3. adverse events

    incidence and intensity of adverse events

    Measured: weekly (max 108 days)

Timeline

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

  1. First posted3 Apr 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMay 2016
  4. Study completionMay 2016

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01569412
Sponsor's protocol ID
ERTUSO
Status last verified
May 2016
First submitted
9 Mar 2012
Last updated
5 May 2016
Results posted
No

Publications

  • Haense N, Atmaca A, Pauligk C, Steinmetz K, Marme F, Haag GM, Rieger M, Ottmann OG, Ruf P, Lindhofer H, Al-Batran SE. A phase I trial of the trifunctional anti Her2 x anti CD3 antibody ertumaxomab in patients with advanced solid tumors. BMC Cancer. 2016 Jul 7;16:420. doi: 10.1186/s12885-016-2449-0.

    PubMed 27387446

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ertumaxomab in people with Her2/Neu Positive Advanced Solid Tumors, run by Krankenhaus Nordwest at 1 site in Germany.

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 13 inclusion and 22 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 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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. 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?

maximum tolerated dose (time frame: every week until end of treatment (max. 108 days)). 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 NCT01569412, which also lists 1 linked publication.

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 5 May 2016.

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