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drugset / Trial / NCT04376931

A Prospective Dose Finding Study of Iscador Infusion

NCT04376931 ↗

Phase 1/2 Unknown 24 enrolled HaEmek Medical Center, Israel
NaSingle-groupOpen-labelTreatment

Summary

Prospective, dose-escalating mono-center open label dose-finding study without control group (3+3 design), including a follow-up on-treatment observation. In this study will be recruited 15 patients with a histologically or cytologically confirmed diagnosis of an advanced malignant disease during a therapy-free interval.Investigational drug:Iscador®P: fermented aqueous extract of mistletoe grown on pine tree (Viscum album L. subspecies austriacum (Wiesb.) Vollmann), licensed for subcutaneous (SC) application in Switzerland, Germany, Austria, Sweden, and South Korea in dosages up to 20 mg. The initial dose group of the study is set to 40 mg Iscador®P.

Timeline

Start
2020-12-01
Primary completion
2022-07-01
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Iscador*P Unknown 10 mg Intravenous
Subject Iscador*P Unknown 20 mg Intravenous
Subject Iscador*P Unknown 40 mg Intravenous
Subject Iscador*P Unknown 90 mg Intravenous
Subject Iscador*P Unknown 140 mg Intravenous
Subject Iscador*P Unknown 200 mg Intravenous

Indications

No indication recorded.