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CompletedNCT02204033Updated Jul 30, 2014

Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody (hMAb) BIWA 4 in Patients With Head and Neck Cancer

A Phase 1 interventional study of 99mTc - labelled hMAb BIWA 4 and 186 Re - labelled hMAb BIWA 4 in Head and Neck Neoplasms, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-30.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The general aim of the present study was to assess the safety and tolerability of intravenously administered Technetium 99m (99mTc) and Rhenium-186 radionuclide (186 Re) -labelled hMAb BIWA 4, to confirm preferential accumulation in the tumour of 99mTc - labelled hMAb BIWA 4, to determine the maximum tolerated radiation dose of 186 Re-labelled hMAb BIWA 4 and to propose a safety dose for phase II development.

02

Conditions studied

  • Head and Neck Neoplasms
03

In context

Head and Neck Neoplasms

2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.

This study's enrollment of 33 is below the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with histological confirmation of squamous cell carcinoma in the head and neck
  • Patients destined for surgery by means of neck dissection (Part A) or :
  • Patients with either local and/or regional recurrent disease for which curative treatment options were not available or distant metastases. The tumor deposits had to be measurable either clinically or by one or more radiological technique (s) (CT, MRI, bone scintigraphy). Because RIT was expected to be more effective in smaller size tumor deposits, patients with lesions measuring > 3 cm in greatest dimension were preferred (Part B)
  • Patients over 18 years of age
  • Patients younger than 80 years of age
  • Patients who had given 'written informed consent'
  • Patients with a life expectancy of at least 3 months
  • Patients with a good performance status: Karnofsky > 60

Exclusion criteria

Exclusion Criteria:

  • Life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on ECG or unstable angina pectoris

  • Pre-menopausal women (last menstruation \<= 1 year prior to study start)

    • Not surgically sterile (hysterectomy, tubal ligation) and
    • Not practicing acceptable means of birth control, (nor not planned to be continued throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives
  • Women with a positive serum pregnancy test at baseline
  • Chemotherapy or radiotherapy within 4 weeks before inclusion in the study
  • White blood cell count \< 3000/mm³, granulocyte count \< 1500/mm³ or platelet count \< 100000/mm³
  • Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    99mTc - labelled hMAb BIWA 4 - low dose

    Drug: 99mTc - labelled hMAb BIWA 4 · Drug: unlabelled hMAb BIWA 4 - low dose

  • Experimental
    99mTc - labelled hMAb BIWA 4 - medium dose

    Drug: 99mTc - labelled hMAb BIWA 4 · Drug: unlabelled hMAb BIWA 4 - medium dose

  • Experimental
    99mTc - labelled hMAb BIWA 4 - high dose

    Drug: 99mTc - labelled hMAb BIWA 4 · Drug: unlabelled hMAb BIWA 4 - high dose

  • Experimental
    186 Re - labelled hMAb BIWA 4 - escalating dose

    Drug: 186 Re - labelled hMAb BIWA 4

Interventions

  • Drug99mTc - labelled hMAb BIWA 4
  • Drug186 Re - labelled hMAb BIWA 4
  • Drugunlabelled hMAb BIWA 4 - low dose
  • Drugunlabelled hMAb BIWA 4 - medium dose
  • Drugunlabelled hMAb BIWA 4 - high dose
06

What researchers measure

Primary outcomes

  1. Number of patients with adverse events

    Time frame: up to 10 weeks

  2. Presence of human-anti-human-antibody (HAHA)

    Time frame: after 144 hours post infusion

  3. Number of patients with clinically significant changes in vital signs

    Time frame: up to 6 weeks after infusion

  4. Biodistribution of 99mTC-labelled hMAb BIWA 4 in tumour and normal tissue samples - Biopsy (Part A)

    uptake expressed as percentage of the injected dose per kg tissue (%ID/kg)

    Time frame: at 48 h after infusion

  5. Immunoscintigraphic imaging evaluation (Parts A + B)

    Time frame: up to 21 hours after infusion

  6. AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 336 hours after infusion

  7. Cmax (Maximum measured concentration of the analyte in plasma)

    Time frame: up to 336 hours after infusion

  8. tmax (Time from dosing to the maximum concentration of the analyte in plasma)

    Time frame: up to 336 hours after infusion

  9. t½ (Terminal half-life of the analyte in plasma)

    Time frame: up to 336 hours after infusion

  10. Vz (Apparent volume of distribution during the terminal phase)

    Time frame: up to 336 hours after infusion

  11. Vss (Apparent volume of distribution under steady-state conditions)

    Time frame: up to 336 hours after infusion

  12. CL (Total body clearance)

    Time frame: up to 336 hours after infusion

  13. MRT (Mean residence time)

    Time frame: up to 336 hours after infusion

  14. Cumulative urinary excretion of radioactivity over time

    Time frame: up to 96 hours after infusion

  15. Number of patients with abnormal changes in laboratory parameters

    Time frame: up to 6 weeks after infusion

  16. Occurence of dose limiting toxicities (DLT)

    Time frame: up to 144 hours post infusion

  17. Uptake of 99mTC-labelled hMAb BIWA 4 in tumour and normal tissue samples (Part A)

    Assessment of biodistribution by radioimmunoscintigraphy expressed as low, medium or high

    Time frame: up to 6 weeks after infusion

  18. Actual organ uptake of 99mTC-labelled hMAb BIWA 4

    expressed as % I.D. (injected dose)

    Time frame: at 21 h after infusion

Secondary outcomes

  1. Tumour response according to response criteria of the World Health Organisation (WHO)

    assessed by Computer Tomography (CT) and/or by Magnet resonance imaging (MRI) and/or bone scintigraphy and/or by physical examination

    Time frame: up to 144 hours after infusion

  2. Maximum tolerated radiation dose of 186Re-labelled hMAb BIWA 4

    Time frame: up to 144 hours after infusion

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 1999 and a primary completion of Jun 2001. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2014
First posted
Jul 30, 2014
Start
Mar 1999
Primary completionActual
Jun 2001
Last update
Jul 30, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02204033
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 30, 2014
Start date
Mar 1999
Primary completion
Jun 2001
Last update
Jul 30, 2014
View the source record on ClinicalTrials.gov ↗

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