A Phase I Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Head and Neck Cancer

NCT02204033 Phase 1 COMPLETED

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.

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	COMPLETED
Enrolment	33
Start date	1999-03

Conditions

• Head and Neck Neoplasms

Interventions

• 99mTc - labelled hMAb BIWA 4
• 186 Re - labelled hMAb BIWA 4
• unlabelled hMAb BIWA 4 - low dose
• unlabelled hMAb BIWA 4 - medium dose
• unlabelled hMAb BIWA 4 - high dose

Primary outcomes

• Number of patients with adverse events — up to 10 weeks
• Presence of human-anti-human-antibody (HAHA) — after 144 hours post infusion
• Number of patients with clinically significant changes in vital signs — up to 6 weeks after infusion
• Biodistribution of 99mTC-labelled hMAb BIWA 4 in tumour and normal tissue samples - Biopsy (Part A) — at 48 h after infusion
  uptake expressed as percentage of the injected dose per kg tissue (%ID/kg)
• Immunoscintigraphic imaging evaluation (Parts A + B) — up to 21 hours after infusion
• AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) — up to 336 hours after infusion