Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Pancreatic Cancer

Sponsor
Zhejiang Provincial People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03645148
Collaborator
Hangzhou Neoantigen Therapeutics Co., Ltd. (Industry)
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Study Details

Study Description

Brief Summary

This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced pancreatic cancer. 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 pancreatic 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: iNeo-Vac-P01
  • Other: GM-CSF
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety, Tolerability and Partial Efficacy Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Pancreatic Cancer
Actual Study Start Date :
Oct 24, 2017
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: iNeo-Vac-P01

Personal Cancer Vaccine: iNeo-Vac-P01 (peptides)+ GM-CSF; Peptides: 4 x 100 mcg per peptide given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses; GM-CSF: 4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses

Biological: iNeo-Vac-P01
Neoantigen peptides

Other: GM-CSF
immune adjuvant
Other Names:
  • granulocyte-macrophage colony stimulating factor
  • Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate [2 years]

    2. Number of participants experiencing clinical and laboratory adverse events (AEs) [1 year]

    Secondary Outcome Measures

    1. Overall Survival Rate [2 years]

    2. Progression Free Survival [2 years]

    Other Outcome Measures

    1. Measurement of CD4/CD8 T lymphocyte subsets [2 years]

    2. The polypeptide antigen - induced IFN-γ T cells responses [2 years]

    3. Peripheral blood T cell receptor sequencing analysis [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Must freely sign informed consent;

    • Aged 18 to 70 years old;

    • The expected survival period is more than 6 months;

    • ECOG score is 0 or 1;

    • Advanced pancreatic cancer diagnosed by Pathology and imageology;

    • Tumor cannot be excised by surgery, and multiline chemotherapy, radiation, targeted therapy fails, or other treatments cannot be tolerated;

    • At least one measurable lesions;

    • To be able to obtain sufficient tumor tissue samples and blood samples for analysis, or to have genomic/exon/transcriptional data of tumor tissues and normal tissues, and the data meet the analysis requirements;

    • The main organs function is normal, such as the heart, liver and kidney;

    • Haematological index:

    neutrophil count≥1.5×10e9/L hemoglobin≥10g/dL platelet count≥100×10e9/L

    • Biochemical index:

    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

    • Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;

    • Good compliance, able to follow research protocols and follow-up procedures.

    Exclusion Criteria:
    • Diagnosed as other malignant tumor;

    • There have been bone marrow or stem cell transplants;

    • No neoantigen was found in the sequencing data;

    • Systemic cancer treatment or other drugs under study were treated within 4 weeks prior to Individualized tumor targeted polypeptides treatment;

    • Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;

    • Active bacterial or fungal infections identified clinically (>= level 2 of NCI-CTC edition 3);

    • Patients with HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;

    • Severe coronary or cerebrovascular disease, or other diseases that the investigators considered should to be exclusion;

    • Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;

    • Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Zhejiang Provincial People's Hospital
    • Hangzhou Neoantigen Therapeutics Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Liu Yang, MD, Zhejiang Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03645148
    Other Study ID Numbers:
    • INEO-P-001
    First Posted:
    Aug 24, 2018
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Liu Yang, MD, Zhejiang Provincial People's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021