Completed

NCT Number: NCT01058616

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.

Completed

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Key information

Conditions

Cancer With Transdermal Accessible Tumour

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oslo University Hospital, Radiumhospitalet, Oslo, Norway

About this study

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:

Histologically confirmed malignant tumour
Transdermally accessible lesion (in or close to the skin)
Age ≥ 18 years
ECOG Performance status (PS): 0 - 2
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LTX-315 (Oncopore™)

Drug

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.

Primary outcomes

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.

Time frame: 12 weeks

Secondary outcomes

Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.

Time frame: 12 weeks
Core biopsy staining for lymphocyte infiltratio

Time frame: 12 weeks
Tumour volume measurment

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Lytix Biopharma AS

Industry

Collaborators

Karolinska University Hospital
Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jan 28, 2010
Registry last updated: Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.