Trials / Completed
CompletedNCT02204033
Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody (hMAb) BIWA 4 in Patients With Head and Neck Cancer
A Phase I Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Head and Neck Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 99mTc - labelled hMAb BIWA 4 | |
| DRUG | 186 Re - labelled hMAb BIWA 4 | |
| DRUG | unlabelled hMAb BIWA 4 - low dose | |
| DRUG | unlabelled hMAb BIWA 4 - medium dose | |
| DRUG | unlabelled hMAb BIWA 4 - high dose |
Timeline
- Start date
- 1999-03-01
- Primary completion
- 2001-06-01
- First posted
- 2014-07-30
- Last updated
- 2014-07-30
Source: ClinicalTrials.gov record NCT02204033. Inclusion in this directory is not an endorsement.