Kurzfassung

TriN 2755 is a cytotoxic active compound based on triazene chemistry. Potential clinical indications are treatments of cancer diseases such as colon cancer, breast cancer, and melanoma. Therefore, the drug is planned to be developed in these clinical indications. TriN 2755 has not yet been administered to humans. The proposed clinical trial is the first entry-in-man study planned to assess the safety and tolerability as well as the pharmacokinetic characteristics of TriN 2755 in humans using...
TriN 2755 is a cytotoxic active compound based on triazene chemistry. Potential clinical indications are treatments of cancer diseases such as colon cancer, breast cancer, and melanoma. Therefore, the drug is planned to be developed in these clinical indications. TriN 2755 has not yet been administered to humans. The proposed clinical trial is the first entry-in-man study planned to assess the safety and tolerability as well as the pharmacokinetic characteristics of TriN 2755 in humans using two different dosage regimen after an intravenous infusion over 4 hours. It is also planned to obtain confirmatory information on the expected molecular mechanism of action of TriN 2755 and to store patients’ leucocyte DNA samples for potential analysis of genetic polymorphisms with regard to safety, efficacy and pharmcokinetics of TriN 2755.

The infusion schedules are:
Schedule A: once every 28 days in a 4-week cycle
Schedule B once every 7 days for 4 weeks in a 4-week cycle
The two different dosing schedules are chosen to maximize exposure of tumor tissue to TriN 2755 and to minimize systemic dose limiting toxicity.
 


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