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Advanced Solid TumorEarly Phase 1NCT05916248

Combination Therapy of Personalized mRNA-0217 Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors

A Early Phase 1 study testing Personalized neoantigen tumor vaccine and PD-1 inhibitor in people with Advanced Solid Tumor, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Personalized neoantigen tumor vaccine and PD-1 inhibitor
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
20 Dec 2023to 30 Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • Has had chemotherapy, hormone therapy, traditional Chinese medicine with antitumor indications, or other antitumor therapies deemed to conflict with the current treatment by the investigator within 4 weeks prior to the first administration of the study drug
  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xinjing Wang contact

18817821319

newvista89@163.com

China1 site, 1 recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Baiyong Shen, Ph.D&M.D, 0086-021-64370045

    Baiyong Shen, Ph.D&M.D

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Personalized neoantigen tumor vaccine, PD-1 inhibitor
Keywords
Personalized neoantigen tumor vaccine, PD-1 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized neoantigen tumor vaccineBiological

    Neoantigen tumor vaccine

  • PD-1 inhibitorBiological

    pembrolizumab

Study groups in NCT05916248
Study groupRoleWhat they receive
Neoantigen tumor vaccine and pembrolizumab combination armExperimentalDose Escalation Phase vaccine: 0.2mg, 0.4mg, 1mg Dose Expansion Phase vaccine : MTD or 1mg Pembrolizumab: 200mg/dose
Receives: Biological: Personalized neoantigen tumor vaccine; Biological: PD-1 inhibitor
Neoantigen tumor vaccine monotherapy armExperimentalDose Escalation Phase vaccine: 0.2mg, 0.4mg, 1mg Dose Expansion Phase vaccine : MTD or 1mg
Receives: Biological: Personalized neoantigen tumor vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) or Dose-limiting toxicity(DLT)

    Measured: Day1 to Day21

  2. Percentage of Participants With Adverse Events (AEs)

    Percentage of Participants with Adverse Events (AEs) by Severity According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: Up to 54 weeks

  3. Biologically Effective Dose (BED).

    if MTD is not reached, BED will be used.

    Measured: Day1 to Day21

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    Progression-free Survival of Personalized mRNA Tumor Vaccine

    Measured: Up to 54 weeks

  2. overall survival (OS)

    Overall Survival of Personalized mRNA Tumor Vaccine

    Measured: Up to 54 weeks

  3. Reaction of antigen-specific T cells in peripheral blood

    mRNA-0217/S001 personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses

    Measured: Up to 54 weeks

  4. Objective response rate (ORR)

    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.

    Measured: Up to 54 weeks

  5. disease control rate (DCR)

    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.

    Measured: Up to 54 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start20 Dec 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This clinical trial adopts Bayesian optimal interval (BOIN) design method to determine the maximum tolerated dose (MTD).
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916248
Sponsor's protocol ID
2021PCV001
Status last verified
Jul 2024
First submitted
2 Jun 2023
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Personalized neoantigen tumor vaccine and PD-1 inhibitor in people with Advanced Solid Tumor, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xinjing Wang (18817821319, newvista89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) or Dose-limiting toxicity(DLT) (time frame: Day1 to Day21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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