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

• 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