A Phase I, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
This clinical study has two main aims which are:
- To measure the immunological effects of LTX-315 in combination with GV1001
- Find out about the side effects of the combination of the two drugs This is an open
label, single centre study assessing immunological effects and safety of LTX-315 given
as an adjunct to GV1001. The LTX-315 dose will escalate while the GV1001 dose will be
LTX-315 and GV1001 will be given as intradermal injections on days 1, 8, 15, 22 and 36.
Investigational treatment: LTX-315 (0.10 mL) with escalating concentrations will be injected
intradermally, followed, 1-2 hours later, by intradermal injection of 0.56 mg GV1001 (0.20
mL, 2.8 mg/mL) in the same site, in one arm.
DTH-test control: 0.10 mg GV1001 (0.10 mL) will be injected intradermally in the
contralateral arm without LTX-315, as a DTH skin reactivity test control.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.
Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment.
5 injections, treatment period 36 days
Tone Nordøy, MD, PhD
Tromsø University Hospital
Norway: Norwegian Medicines Agency