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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lytix Biopharma AS
• Collaborator: Kael-GemVax Co., Ltd.

Criteria

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