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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer With Transdermal Accessible Tumour

Intervention / Treatment
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* Drug: LTX-315 (Oncopore™)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |