NCT01058616

Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour

Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Lytix Biopharma AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect in animal models to kill cancer tumours when injected directly in to the tumour. The study will also monitor the immunological response in the body after injection of LTX-315.

Detailed description

A phase I study with an initial concentration/volume escalating part followed by an expanded cohort at the recommended dose (RD). This is an open label, multicentre study assessing the safety, tolerance, PK and efficacy of LTX-315 injected directly into transdermally accessible tumours on days 1 and 8. Additional weekly injections may be made, for up to a total of 6 injections. Subjects may be included in the study if they meet all of the following criteria: 1. Histologically confirmed malignant tumour 2. Transdermally accessible lesion (in or close to the skin) 3. Age ≥ 18 years 4. ECOG Performance status (PS): 0 - 2 5. Life expectancy: At least 3 months The primary objectives of the study are to evaluate the safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study and to determine the recommended dose of LTX-315. The secondary objectives of the study are to preliminarily assess the anti-tumour activity of LTX-315 in patients with transdermally accessible tumours, monitor immunological response, pharmacokinetic assessment, and determine duration of response.

Conditions

• Cancer With Transdermal Accessible Tumour

Interventions

Type	Name	Description
DRUG	LTX-315 (Oncopore™)	5 mg/ml-70 mg/ml. Dosing will be done as transdermal injection of a calculated volume at day 1 and 8. Additionally weekly injections up to a maximum of 4 injections.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2010-01-28
• Last updated: 2013-02-11

Locations

2 sites across 2 countries: Norway, Sweden