Spots Global Cancer Trial Database for A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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