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

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.

Study Overview

• Status: Completed
• Conditions: Cancer With Transdermal Accessible Tumour
• Intervention / Treatment: Drug: LTX-315 (Oncopore™)

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0310
    • Oslo University Hospital, Radiumhospitalet
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital, Solna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Lytix Biopharma AS
• Collaborators: Karolinska University Hospital; Oslo University Hospital
• Investigators: Principal Investigator: Paal Brunsvig, MD, PhD, Oslo University Hospital, Radiumhosptalet, Oslo, Norway

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 27, 2010
• First Submitted That Met QC Criteria: January 27, 2010
• First Posted (Estimate): January 28, 2010

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 8, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: C08-315-01