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
Lead SponsorLytix Biopharma AS
StatusCompleted No Results Posted
Indication/ConditionCancer With Transdermal 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.
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.
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.
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