Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Malignant Tumor
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03662815 |
Recruitment Status :
Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : September 4, 2019
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Tracking Information | |||||
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First Submitted Date ICMJE | September 5, 2018 | ||||
First Posted Date ICMJE | September 7, 2018 | ||||
Last Update Posted Date | September 4, 2019 | ||||
Actual Study Start Date ICMJE | February 7, 2018 | ||||
Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Malignant Tumor | ||||
Official Title ICMJE | Safety, Tolerability and Partial Efficacy Study of a Personalized Neoantigen Cancer Vaccine inTreating Patients With Advanced Malignant Tumor | ||||
Brief Summary | This research study is evaluating a new type of cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced malignant tumor. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients with advanced malignant cancer, so as to provide a new personalized therapeutic strategy for advanced pancreatic cancer patients. It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Malignant Solid Tumor | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: iNeo-Vac-P01
Personal Cancer Vaccine: iNeo-Vac-P01 (peptides)+ GM-CSF; Peptides: 0.1 or 0.3 mg per peptide given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses. Additional booster vaccines might be administered depending on ethics and patients' potential benefit. GM-CSF: 40 mcg given 30 minutes before iNeo-Vac-P01. Interventions:
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 2021 | ||||
Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
neutrophil count≥1.5×109/L hemoglobin≥10g/dL platelet count≥100×109/L
Total bilirubin is less than or equal to 1.5 times the upper limit of normal value (ULN) AST and ALT is less than or equal to 2.5 times the upper limit of normal value Serum creatinine and urea nitrogen (BUN) is less than or equal to 1.5 times the upper limit of normal value
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03662815 | ||||
Other Study ID Numbers ICMJE | INEO-P-002 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Yong Fang, Sir Run Run Shaw Hospital | ||||
Study Sponsor ICMJE | Sir Run Run Shaw Hospital | ||||
Collaborators ICMJE | Hangzhou Neoantigen Therapeutics Co., Ltd. | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Sir Run Run Shaw Hospital | ||||
Verification Date | September 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |