NCT02994771

A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema

A Phase I Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of Lymfactin® (AdAptVEGF-C Adenoviral Vector) in Combination With a Surgical Lymph Node Transfer for the Treatment of Patients With Secondary Lymphedema

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Herantis Pharma Plc. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer. Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer.

Detailed description

This is an open label, multi-center, uncontrolled first in human trial that uses a standard 3 + 3 dose escalation scheme. Lymfactin® will be administered as a single dose by ex vivo perinodal injection into the fat pad of a flap of tissue containing lymph nodes from the abdominal wall. This flap of tissue will then be surgically implanted into the axillary region of the affected arm. This treatment with Lymfactin® may be performed in conjunction with or without breast reconstruction surgery. Up to two dose cohorts are planned to be included. Each dose of Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL: * Cohort 1: Lymfactin® \[1 x 10E10 vp\] * Cohort 2: Lymfactin® \[1 x 10E11 vp\] Should the dose escalation go up to Cohort 2 with initiation of a subsequent Extension Cohort a total of 15 - 21 patients may be treated in this study.

Conditions

• Secondary Lymphedema

Interventions

Type	Name	Description
DRUG	Lymfactin® [1 x 10E10 vp]	Lymfactin® \[1 x 10E10 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.
DRUG	Lymfactin® [1 x 10E11 vp]	Lymfactin® \[1 x 10E11 vp\] will be administered as a single dose via perinodal injection in a volume of 2 mL.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-02-03
• Completion: 2022-04-05
• First posted: 2016-12-16
• Last updated: 2023-04-24

Locations

3 sites across 1 country: Finland