Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Paal Brunsvig, MD, PhD
Oslo University Hospital, Radiumhosptalet, Oslo, Norway
Norway: Norwegian Medicines Agency