Carcinoma Clinical Trial
Official title:
A Phase I, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001).
This will be tested in patients that have had surgery with curative intent for malignant
tumour.
GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to
start the immune response in the body to have effect of GV-1001.
LTX-315, also a peptide, in development for cancer treatment. In this study, the
investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating
the immune system.
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
fixed.
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
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