A Single-Patient Study Using AGS 006

Study Overview
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Brief Summary
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Argos Therapeutics, Inc., (Argos) proposes to study AGS-006 in a subject with newly diagnosed resectable pancreatic cancer. The AGS 006 immunotherapeutic may potentially offer a desired additional option to conventional treatments for pancreatic carcinoma.

Detailed Description
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Single-patient, open-label clinical study: Events during Pre-Treatment Period: Resection of pancreatic cancer, RNA acquisition from tumor specimen, RNA amplification, Infectious disease testing, Autoimmune disease testing, Two blood draws for immune response monitoring, Production leukapheresis, and Dendritic cell electroporation with RNA and immunotherapeutic production; Events during Induction Period: Administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses, Two Induction Period blood draws (Week 6 and Week 12) for immune response monitoring, and One leukapheresis (Week 14) for immune response monitoring; Events during Booster Period: Dose every 3 months until progression or 2 years after first AGS treatment, Potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and One blood draw 2 weeks following dosing at Week 36 (1st booster dose) (approximately Week 38); and, Events during study Close-Out: Close-Out upon progression or 28 days following immune response monitoring 2 years after first dose

Official Title
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A Single-Patient Study Using AGS 006 as an Immunotherapeutic in a Subject With Newly Diagnosed Resectable Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: AGS-006


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A male subject 18 years of age or older with newly diagnosed resectable pancreatic cancer who, in the opinion of the investigator, is suitable for participation in the study will be eligible for inclusion if all of the following criteria apply: Able to abstain from taking prohibited prescription or prohibited non-prescription drugs. Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements. Voluntary informed consent given to participate in the study. Exclusion Criteria: Any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment. Active autoimmune disease including, but not limited to: Active, acute, or chronic clinically significant infections including human immunodeficiency virus (HIV) and viral hepatitis. Known hypersensitivity to dimethyl sulfoxide (DMSO). Body weight less than 30 kg.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AGS-006 | Biological: AGS-006<br>* Autologous Therapy for Pancreatic Cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent changes in vital signs (blood pressure, heart rate, respiratory rate, and body temperature) from baseline values obtained prior to each investigative treatment |  |  | 
| Incidence of treatment-emergent adverse events graded according to the Common Terminology Criteria for Adverse Events |  |  | 
| Treatment-emergent adenopathy, tenderness, or inflammation (inguinal and axillary) assessed before and after each dose |  |  | 
| Treatment-emergent changes in autoimmunity evaluations as measured by clinical signs and symptoms and laboratory assessments at periodic intervals during the Treatment Period. |  |  | 
| Treatment-emergent changes in localized injection site reactions following each dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of progression-free survival (PFS) estimated from the date of subject registration - Standard Response Evaluation Criteria in Solid Tumors (RECIST) definitions of progressive disease (PD) will contribute to estimating the interval for PFS. |  |  | 
| T cell response to RNA-electroporated DCs will be assessed by flow cytometry using blood cells collected according to protocol time and events |  |  | 
| Positive immune response |  |  | 
| Feasibility |  |  |