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

Phase 1

Completed

• Conditions: Cancer With Transdermal Accessible Tumour

• Registration Number: NCT01058616
• Lead Sponsor: Lytix Biopharma AS

Brief 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Histologically confirmed malignant tumour. Transdermally accessible lesion (in or close to the skin) of 1 - 5 cm in diameter.
• ECOG Performance status (PS): 0 - 2
• Life expectancy: At least 3 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study. Necrosis of the target tumour based on imaging and core biopsy analysis.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.	12 weeks
Core biopsy staining for lymphocyte infiltratio	12 weeks
Tumour volume measurment	12 weeks

Trial Locations

Locations (2)

Oslo University Hospital, Radiumhospitalet; 🇳🇴 Oslo, Norway

Karolinska University Hospital, Solna; 🇸🇪 Stockholm, Sweden