A Phase I, Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Angiocal® (PRS-050-PEG40) in Patients With Solid Tumors
This is a phase I, open-label, dose escalation study with Angiocal® in patients with solid
tumors using a group sequential adaptive treatment assignment. Patients will be allocated to
different dose levels in small cohorts and will receive one single dose application on Day
1, followed by a repeated dosing period. The primary objective of the study is to evaluate
the safety and tolerability of Angiocal® when administered intravenously to patients with
solid tumors. The secondary objectives of the study are the characterization of the
pharmacodynamic response, evaluation of the pharmacokinetic profile of Angiocal®,
observation of tumor response.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting toxicity
Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.
Throughout the course of the study
Laurent Audoly, PhD
Germany: Federal Institute for Drugs and Medical Devices