- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05916248
Personalized Tumor Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors
October 8, 2023 updated by: Ruijin Hospital
Clinical Study of Personalized Tumor Vaccines mRNA-0217/S001 and Pembrolizumab in Patients With Advanced Solid Tumors
The main objective of this study was to observe and evaluate the safety and tolerability of mRNA-0217/S001 vaccine encoding personalized tumor neoantigens alone/in combination with Pembrolizumab injection for the treatment of advanced solid tumors.
The secondary objective was to observe the preliminary efficacy of mRNA-0217/S001 personalized tumor vaccine in the treatment of advanced solid tumors with neoantigen-specific CD4+ and CD8+ T lymphocyte responses, objective tumor response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) caused by mRNA-0217/S001 personalized tumor vaccine.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xinjing Wang
- Phone Number: 18817821319
- Email: newvista89@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
-
Principal Investigator:
- Baiyong Shen, Ph.D&M.D
-
Contact:
- Baiyong Shen, Ph.D&M.D
- Phone Number: 0086-021-64370045
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Subjects voluntarily signed written informed consent files,Able to comply with the study protocol, in the investigator's judgment
- Subjects must be >/= 18 years of age at time of informed consent, regardless of gender
- Subjects with locally advanced, recurrent or metastatic solid tumors confirmed by histology or cytology within the past 6 months, who have failed standard treatment or are currently not suitable for standard treatment
- No copy number variations (CNVs) or loss of heterozygosity (Loss-of heterozygosity, LOH) were found in HLA-related genes and chromosomal regions by gene sequencing
- Advanced or metastatic lesions confirmed by immunohistochemistry, and cryopreserved tissues/cells, enough for WES and RNAseq sequencing, and predicted by bioinformatics analysis, at least one antigen effectively presented by self-HLA was found , such as KRAS or TP53 mutations and correspondingly presented HLA types
- Life expectancy ≥ 4 months
- Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Have adequate organ and bone marrow function,No use of granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion and platelet transfusion within 14 days before the examination.
- Fertile eligible patients (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) during the trial and at least 90 days after the last dose. female patients of childbearing age before the first dose A blood pregnancy test within 7 days must be negative.
- Subjects need to undergo virological examination: those without CMV and EBV, HIV, HBV, HCV, and syphilis infection (only in the baseline period)
Exclusion Criteria:
- Has had chemotherapy, hormone therapy, traditional Chinese medicine, or biological cancer(for mitomycin and nitrosoureas within 6 weeks from the first dose of the drug in this study), prior to the first dose of study therapy within 4 weeks ,Or within 5 half-lives of immunotherapy, molecular targeted therapy
- Subjects have undergone major surgical procedures other than the diagnosis or biopsy of the current tumor within 4 weeks before the first dose of mRNA-0217/S001, or are expected to undergo major surgery during the study period
- Subjects have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past, or those who plan to receive organ transplantation during this study
- Subjects have previously received other tumor vaccines or cell therapy
- Brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis, or other evidence that the brain and spinal cord metastases have not been controlled, and the researchers judged that they are not suitable for enrollment
- Other malignant tumors known to be progressing or requiring active treatment in the past 2 years (except for non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix that have been cured by surgical curative treatment)
- History of interstitial lung disease (ILD), pulmonary fibrosis
- Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to a) severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular block corrected QTc interval male > 450 milliseconds, female > 470 milliseconds, b) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration, c) New York Heart Association (NYHA) ≥ III heart failure or left ventricular ejection fraction (LVEF) < 50%.
- Other serious and/or uncontrollable diseases, which may affect the subject's participation in this study, include but not limited to a) a history of severe drug allergy, or is known to be allergic to any tumor vaccine and pembrolizumab formulation components or has had severe allergic reactions to other monoclonal antibodies in the past, b) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, c) Evidence of severe or uncontrolled liver or kidney disease, d) Uncontrolled high blood pressure, diabetes, etc., e) Patients with active ulcers, gastrointestinal bleeding, f) Serious infection requiring intravenous antibiotics or hospitalization or uncontrolled active infection within 4 weeks before the first dose, g) have an active syphilis infection.
- Participate in other clinical trials within 4 weeks before the first dose (except for screening failure)
- Those who are currently receiving systemic steroids (except those who have recently or currently used inhaled steroids)
- Pregnant and lactating women
- Imaging (CT or MRI) shows that the tumor invades large blood vessels and has a tendency to hemorrhage
- Have clinically significant thyroid dysfunction, and the investigator judges that they are not suitable for enrollment
- Active pneumonia found in chest CT scan during the screening period
- Uncontrolled pleural effusion, pericardial effusion, or ascites that needs repeated drainage
- Subjects who have adverse reactions of the previous anti-tumor therapy have not recovered to NCI-CTCAE 5.0 grade evaluation ≤ grade 1 (except for hair loss)
- HBsAg positive and peripheral blood HBV DNA detection value is higher than the upper limit of normal, and/or HCV Ab positive and HCV RNA detection value is higher than the upper limit of normal
- Researchers believe that there are other reasons that are not suitable for participating in clinical trials
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Personalized neoantigen vaccine or neoantigen tumor vaccine + Pembrolizumab
In dose escalation phase, subject will only receive personalized neoantigen tumor vaccine.
In dose expansion phase, subject will receive personalized neoantigen tumor vaccine combination with Pembrolizumab
|
Neoantigen tumor vaccine with or without Pembrolizumab In dose escalation phase, subjects will receive neoantigen tumor vaccine only.
In dose expansion phase, subjects will receive neoantigen tumor vaccine combination with Pembrolizumab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD) or Dose-limiting toxicity(DLT),If MTD is not reached, Biologically Effective Dose (BED)
Time Frame: Up to 27 weeks
|
The highest dose of a drug or treatment that does not cause unacceptable side effects.
|
Up to 27 weeks
|
Reaction of antigen-specific T cells in peripheral blood
Time Frame: Up to 27 weeks
|
mRNA-0217/S001 personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses
|
Up to 27 weeks
|
Objective response rate (ORR)
Time Frame: Up to 105 weeks
|
ORR calculates the ratio of the number of patients whose best response is complete remission (CR) or partial remission (PR) to the total number of evaluable patients according to RECIST 1.1 criteria.
Those who have not been evaluated for lesion and tumor response will be regarded as non-evaluable patients and will not be counted.
|
Up to 105 weeks
|
disease control rate (DCR)
Time Frame: Up to 105 weeks
|
DCR calculates the ratio of the number of patients whose best response is complete remission (CR), or partial remission (PR), or stable disease (SD) to the total number of evaluable patients according to RECIST 1.1 criteria.
Those who have not been evaluated for lesion and tumor response will be regarded as non-evaluable patients and will not be counted.
|
Up to 105 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Up to 105 weeks
|
Progression-free Survival of Personalized mRNA Tumor Vaccine
|
Up to 105 weeks
|
overall survival (OS)
Time Frame: Up to 3 years
|
Overall Survival of Personalized mRNA Tumor Vaccine
|
Up to 3 years
|
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 105 weeks
|
According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
|
Up to 105 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Baiyong Shen, M.D.&Ph.D, Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2023
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
June 2, 2023
First Submitted That Met QC Criteria
June 14, 2023
First Posted (Actual)
June 23, 2023
Study Record Updates
Last Update Posted (Estimated)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021PCV001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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