Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN)

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.

Timeline

Start

2023-03-28

Primary completion

2025-01-17

Completion

2025-01-17

Drugs

Indications