Trial Information

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.