Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN)
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
This is a multicentre open labelled phase I trial evaluating the safety and preliminary
efficacy of local decitabine treatment of human papillomavirus (HPV)-induced vulvar
intraepithelial neoplasia (VIN) grade 2/3.
The main purpose and primary objective of the study is to determine the recommended phase 2
dose (RP2D) of VTD-101 ointment for the topical treatment of HPV-induced VIN grade 2/3. The
RP2D is defined as the dose that is safe, tolerable and effective. Corresponding endpoints
are the rate of patients experiencing at least one dose limiting toxicity (DLT) and the rate
of patients with clinical complete or partial response (cCR/cPR) according to adapted RECIST
criteria.
Secondary objectives are to further characterize the efficacy of topical treatment with
VTD-101 ointment, to further evaluate the safety and tolerability of topical treatment with
VTD-101 ointment, and to evaluate quality of life (QoL) in patients treated with VTD-101
ointment.
Phase:
Phase 1
Details
Lead Sponsor:
ViMREX GmbH
Collaborator:
Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest