MVX-ONCO-1 in Patients With Solid Tumor

Study Overview
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Brief Summary
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The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.

Detailed Description
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Endpoints: Primary: To assess safety parameters including adverse and serious adverse events (incidence, causality, severity), local and systemic tolerance to the administered study treatment, changes in laboratory values and vital signs in patients with solid tumor; Secondary: to measure some tumor responses in using imaging technique, serological tumor markers, immune monitoring and metabolic monitoring.

Official Title
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An Open Phase I Clinical Study Assessing Safety and Tolerability of MVX-ONCO-1 in Patients With Solid Tumor Who Are Not/Not Any Longer Amenable to Standard Therapy

Conditions
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Solid Tumor, Cancer

Intervention / Treatment
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* Other: Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged 18 years and older with advanced metastatic cancer in progression of various sites [Carcinoma of lung (either small cell or non-small cell), colon, breast, pancreas (exocrine or endocrine), stomach, oesophagus, head&neck, thyroid, kidney, bladder, prostate, ovary, uterus (cervix or corpus); Sarcoma of soft tissue, bone, uterus, melanoma; primary brain tumor] where all recognized treatment are exhausted or not feasible. Life expectancy: estimate of at least 4 months. Exclusion Criteria: Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks. Have received any chemotherapy treatment in the 4 preceding weeks. Serious concomitant health condition such as organ transplant requiring immunosuppressive drugs, severe psychiatric disorders. History of second cancer within the last 2 years with the exception of basal cell carcinoma of skin and localized cervical carcinoma treated with curative intent. Patient with a systemic disease other than cancer, that is not controlled by usual medication. Therapeutic anticoagulation with coumarine or continues iv heparin. Low-molecular weight heparin (LMWH) is permitted as long as treatment can be withheld several hours prior to subcutaneous implantation. Positive HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B surface antigen, or hepatitis C antibody.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>MVX-1-loaded capsules and injection of irradiated autologous tumor cells | Other: Treatment<br>* Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells<br>* Other names: - irradiated autologous tumor cells (cell therapy);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Adverse Events and/or Serious Adverse Events | Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity. | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed type hypersensitivity reactions, Induction of a specific CD8 response | immune monitoring | 18 weeks | 
| imaging and metabolic monitoring |  | 18 weeks | 
| tumor size | document of tumor number, sites, size of lesions | 18 weeks | 
| tumor pain | intensity, site, frequency of pain, use of analgesics | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, solid tumors, gene therapy, cell therapy, encapsulation