drugset / Trial / NCT02204033
Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody (hMAb) BIWA 4 in Patients With Head and Neck Cancer
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 1999-03
- Primary completion
- 2001-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 186 Re - labelled hMAb BIWA 4 | Monoclonal antibody | — | Intravenous |
| Subject | 99mTc - labelled hMAb BIWA 4 | Monoclonal antibody | — | Intravenous |
| Subject | unlabelled hMAb BIWA 4 | Monoclonal antibody | — | — |