Carcinoma
Conditions
Keywords
Cancer, Carcinoma, Curative surgery, Curative surgery for carcinoma at least three months and not more than 5 years prior to treatment start
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.
Interventions
DRUGLTX-315
0.25-2.0 mg/ML, maximum 5 injections during 36 days.
Sponsors
Kael-GemVax Co., Ltd.
Lytix Biopharma AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood. | 5 injections, treatment period 36 days | Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety profile of LTX-315 in combination with GV1001 study | 5 injections, treatment period 36 days | Assessment of adverse events and abnormal laboratory values recorded during the |
Countries
Norway
Outcome results
None listed