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

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
Sponsor:
Collaborator:
Hangzhou Neoantigen Therapeutics Co., Ltd.
Information provided by (Responsible Party):
Yong Fang, Sir Run Run Shaw Hospital

Tracking Information
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
 (submitted: September 5, 2018)
  • Objective Response Rate [ Time Frame: 2 years ]
  • Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • Overall Survival Rate [ Time Frame: 2 years ]
  • Progression Free Survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 5, 2018)
  • Measurement of CD4/CD8 T lymphocyte subsets [ Time Frame: 2 years ]
  • The polypeptide antigen - induced IFN-γ T cells responses [ Time Frame: 2 years ]
  • Peripheral blood T cell receptor sequencing analysis [ Time Frame: 2 years ]
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.

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
Condition  ICMJE Advanced Malignant Solid Tumor
Intervention  ICMJE
  • Biological: iNeo-Vac-P01
    Neoantigen peptides
  • Other: GM-CSF
    immune adjuvant
    Other Name: granulocyte-macrophage colony stimulating factor
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:
  • Biological: iNeo-Vac-P01
  • Other: GM-CSF
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
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:

  • Must freely sign informed consent;
  • Aged 18 to 75 years old;
  • The expected survival period is more than 6 months;
  • ECOG score is 0 or 1;
  • Patients with advanced tumors who fail to receive standard therapy, and those who are not suitable or refuse standard adjuvant therapy;
  • Advanced malignant cancer diagnosed by pathology and imageology;
  • 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≥1.5×109/L

hemoglobin≥10g/dL

platelet count≥100×109/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, but cured basal cell carcinoma, thyroid carcinoma, cervical dysplasia etc is excluded;
  • No neoantigen was found in the sequencing data;
  • There have been bone marrow or stem cell transplants;
  • 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;
  • People infected with herpes virus (scabbed for more than 4 weeks is excluded);
  • People infected with respiratory virus (cured for more than 4 weeks is excluded);
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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