Cancer With Transdermal Accessible Tumour
Conditions
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.
Interventions
DRUGLTX-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.
Sponsors
Oslo University Hospital
Karolinska University Hospital
Lytix Biopharma AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
Norway, Sweden
Outcome results
None listed