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

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.

Inclusion Criteria:

• Curative surgery for carcinoma performed at least three months prior to treatment start

• Age ≥18 years

• ECOG Performance status (PS): 0

• Life expectancy: at least 3 months

• Laboratory requirements:

  • White Blood Count (WBC) ≥ 3 x 109/L
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Haemoglobin ≥ 10.0 g/dL
  • Total bilirubin level ≤ 1.5 ULN
  • AST and ALT ≤ 2.5 x ULN
  • Creatinine ≥ 1.5 ULN
  • Albumin > 30 g/L

• No expectation of anti-cancer therapy or immunotherapy during the trial period, hormone therapy given as adjunctive or contraceptive therapy is permitted

• Must be willing to practice acceptable barrier methods of birth control to prevent pregnancy

• The patient is willing and able to comply with the protocol and agrees to return to the hospital for follow-up visits and examination

• The patient has been fully informed about the study and has signed the informed consent form

Exclusion Criteria:

• Has received an investigational drug within 4 weeks prior to study drug administration, or is scheduled to receive one during the treatment or the post-treatment period

• Has received immunotherapy or been vaccinated within 12 weeks prior to study drug administration or has not recovered from adverse events due to such agents

• Has received external radiotherapy or cytotoxic chemotherapy within the last 4 weeks prior to study drug administration, or has not recovered from adverse events (< Grade 1) due to agents administered more than 4 weeks earlier

• Has received imiquimod within 12 weeks prior to study drug administration or has not recovered from associated adverse events

• Is currently on any agent with a known effect on the immune system

• Has any other serious illness or medical condition such as but not limited to:

  • Any uncontrolled infection or infection requiring antibiotics
  • Uncontrolled cardiac failure Classification III or IV (New York Heart Association)
  • Uncontrolled systemic and gastro-intestinal inflammatory conditions
  • Bone marrow dysplasia
  • History of auto-immune disease
  • History of adverse reaction to vaccines

• Known history of positive tests for HIV/AIDS, hepatitis B or C

• Is pregnant or breastfeeding