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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carcinoma

Intervention / Treatment
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* Drug: LTX-315


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTX-315<br>The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001. | Drug: LTX-315<br>* 0.25-2.0 mg/ML, maximum 5 injections during 36 days.<br>* Other names: GV-1001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood. | 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. | 5 injections, treatment period 36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety profile of LTX-315 in combination with GV1001 study | Assessment of adverse events and abnormal laboratory values recorded during the | 5 injections, treatment period 36 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Carcinoma, Curative surgery, Curative surgery for carcinoma at least three months and not more than 5 years prior to treatment start