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Digestive System NeoplasmsPhase 1NCT06026774

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Subjects With Resected Digestive System Neoplasms

A Phase 1 study testing iNeo-Vac-R01 in combination with standard adjuvant therapy in people with Digestive System Neoplasms, run by Sir Run Run Shaw 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
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Trial summary

The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Digestive System Neoplasms
What is being tested?
iNeo-Vac-R01 in combination with standard adjuvant therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
8 Sep 2023to 31 Dec 2027
Phase
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, >/= 18 years old and </= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.
  • Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms listed below that can be radical resected. Subjects must be able to receive at least 4 cycles of standard adjuvant therapy according to CSCO clinical guidelines after surgery. The toxic effects of previous anti-tumor treatments have returned to </= grade 1 defined by NCI-CTCAE v5.0 or to the level specified by the inclusion/exclusion criteria.
  • Subjects with any of the following digestive system neoplasms:
  • Cholangiocarcinoma b. Pancreatic cancer c. Hepatocellular carcinoma d. Gastric cancer e. Colorectal carcinoma
  • Expected survival >/= 6 months.
  • ECOG performance status score of 0 ~ 1.
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  • Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 0.5cm*0.5cm of tissue required for surgical samples.
  • Echocardiographic evaluation: left ventricular ejection fraction (LVEF) >/= 50%.
  • The organ function level must meet the following requirements: absolute neutrophil count (ANC) >/= 1.5 × 10^9/L, platelet count (PLT) >/= 80 × 10^9/L, hemoglobin (Hb) >/= 90 g/L; serum total bilirubin (TBIL) </= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 2.5 × ULN (if there is liver metastasis, TBIL </= 3 × ULN, AST, ALT </= 5 ×ULN are allowed), serum albumin >/= 28g/L, serum creatinine </= 1.5 × BUN, Glomerular filtration rate >/= 50mL/min, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) </= 1.5 × ULN (without anticoagulant therapy) .
  • For women of childbearing potential: having a negative serum or urine pregnancy test within 7 days prior to study initiation, agreement to remain abstinent or use contraceptive measures during the treatment period.
  • For men: agreement to remain abstinent or use contraceptive measures during the treatment period.

Who cannot join

  • Subjects with cancer requiring anti-tumor treatment within the 5 years prior to enrollment in the study (except stage I prostate cancer, cervical cancer in situ, breast cancer in situ, papillary thyroid cancer and non-melanoma skin cancer that have been treated).
  • Subjects who received major surgery, or had obvious traumatic injury or long-term untreated wounds or fractures within 2 weeks prior to the first dose of iNeo-Vac-R01.
  • Subjects whose sequencing data was found that there are no new antigens available for individualized immunotherapy after analysis.
  • Subjects who prepare to undergo or have previously received bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation. Subjects who receive other anti-tumor treatments within 2 weeks prior to the first dose of iNeo-Vac-R01, including surgical treatment, chemotherapy, radiation therapy, targeted therapy, endocrine therapy, immunotherapy, biological therapy, interventional therapy, or other clinical trial related treatments.
  • Subjects who need to use immunosuppressants, or systemic or absorbable local glucocorticoids therapy to achieve immunosuppressive effects and continue to use them within 7 days before the first administration (excluding those with daily doses of glucocorticoids less than 10mg of prednisone or doses of other therapeutic glucocorticoids equal to 10mg of prednisone).
  • Subjects who received other vaccines within 4 weeks before the first dose of iNeo-Vac-R01, and are expected to receive other vaccines during treatment period of the study or within 60 days after the last dose of iNeo-Vac-R01.
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  • Subjects who have an active infection or uncontrollable infection requiring systemic treatment, including fungi, bacteria, viruses, or other infections; subjects with active tuberculosis;
  • Subjects with positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb) and positive hepatitis B virus DNA titer detection greater than normal range; positive hepatitis C virus (HCV) antibody and HCV RNA detection greater than normal range; positive human immunodeficiency virus antibody; positive treponema pallidum-specific antibody.
  • Subjects with autoimmune diseases or immune deficiencies treated with immunosuppressive drugs, except vitiligo, type 1 diabetes, autoimmune hypothyroidism requiring hormone treatment and psoriasis not requiring systemic treatment; known history of primary immunodeficiency.
  • Subjects with cardiocerebrovascular events: previously or currently heart valve disease >/= grade 3, heart failure within 8 weeks before the first dose of iNeo-Vac-R01 (New York Heart Association [NYHA] cardiac function >/= grade II, myocardial infarction, unstable angina, stroke, transient ischemic attack, cardiac surgery (including coronary artery bypass grafting or percutaneous coronary intervention) within 8 weeks before the first dose of iNeo-Vac-R01, concomitant severe electrocardiogram abnormalities (such as ventricular flutter, ventricular fibrillation, multiform ventricular tachycardia, sick sinus syndrome, third degree atrioventricular block without pacemaker treatment, QTc >/= 480ms, and other conditions evaluated by the investigators as severe abnormalities), hypertension with poor drug control (systolic blood pressure >/= 160mmHg and/or diastolic blood pressure >/= 100mmHg), or other cardiocerebrovascular diseases that have been evaluated by the investigators as unsuitable for participation in this trial.
  • Subjects with respiratory disease: previously or currently pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe asthma, pulmonary hypertension or severe impairment of lung function, etc.
  • Subjects with moderate to severe ascites with clinical symptoms; uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.
  • Subjects with drug abuse; clinical or psychological or social factors that affect informed consent or research implementation.
  • Subjects with a history of allergies to immunotherapy or vaccines, or other potential immunotherapy allergies identified by the investigators.
  • Subjects identified that it is not suitable for enrollment or may not be able to complete this experiment for other reasons by the investigators.
  • Vulnerable groups, including individuals with mental illness, cognitive impairment, critical patients, minors, pregnant or lactating women, etc.

Trial locations and contacts

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

Xiujun Cai contact

0086-0571-86006605

caixiujunzju@yahoo.com.cn

China1 site, 1 recruiting

  • Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310000

    Xiujun Cai, MD, 0086-0571-86006605, caixiujunzju@yahoo.com.cn

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard Adjuvant Therapy in Subjects With Resected Digestive System Neoplasms

The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.

Read the detailed description

This is a single-center, open-label, single-arm clinical study of personalized mRNA vaccine iNeo-Vac-R01 in combination with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.

Being tested
iNeo-Vac-R01 in combination with standard adjuvant therapy
Medical subject headings
Digestive System Neoplasms

What participants receive

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

  • iNeo-Vac-R01 in combination with standard adjuvant therapyBiological

    Personalized mRNA vaccine encoding neoantigen, IH injection

Study groups in NCT06026774
Study groupRoleWhat they receive
iNeo-Vac-R01 in combination with standard adjuvant therapyExperimentalSubjects will receive at least 4 cycles of standard adjuvant therapy according to CSCO clinical guidelines after surgery. Then subjects will receive iNeo-Vac-R01 via IH injection on Day 1 of each 21-day cycle for up to 9 cycles at an applicable dose, identified during the dose escalation phase of the study.
Receives: Biological: iNeo-Vac-R01 in combination with standard adjuvant therapy

What is being measured

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

  1. Number of Participants with Adverse Events (AEs) [safety and tolerability]

    Measured: 21 days after last iNeo-Vac-R01 dose

Secondary outcomes (6)

  1. Overall Survival (OS)

    OS is defined as time between the date of the first dose of iNeo-Vac-R01 and the date of death due to any cause.

    Measured: 3 years after first dose of iNeo-Vac-R01

  2. Recurrence Free Survival (RFS)

    RFS is defined as time between the date of first dose of iNeo-Vac-R01 and the date of either disease recurrence or death (whichever is sooner).

    Measured: 3 years after first dose of iNeo-Vac-R01

  3. The proportion of subjects who have no disease recurrence at 12 months or 24 months after first dose of iNeo-Vac-R01.

    Measured: 12 months and 24 months after first dose of iNeo-Vac-R01

  4. Neoantigen-specific T Cell Response [immunogenicity]

    Detect the level of specific TNF-γ in peripheral blood of subjects by ELISpot in order to measure the neoantigen-specific T cell response of subjects.

    Measured: 12 months after first dose of iNeo-Vac-R01

  5. T Cell Subsets [immunogenicity]

    Detect the proportion of different T cell subsets in T cells by flow cytometry.

    Measured: 12 months after first dose of iNeo-Vac-R01

  6. Cytokines Level [immunogenicity]

    Record the changes of IL-2, IL-6, IL-8, IL-10, IL-12, and TNF-α in peripheral blood before and after treatment.

    Measured: 6 months after first dose of iNeo-Vac-R01

Timeline

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

  1. First posted7 Sep 2023
  2. Study start8 Sep 2023 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Dec 2027 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06026774
Sponsor's protocol ID
SRRSH2023-755-03
Status last verified
Sep 2023
First submitted
25 Aug 2023
Last updated
11 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing iNeo-Vac-R01 in combination with standard adjuvant therapy in people with Digestive System Neoplasms, run by Sir Run Run Shaw 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 16 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 11 Sep 2023. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Xiujun Cai (0086-0571-86006605, caixiujunzju@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) [safety and tolerability] (time frame: 21 days after last iNeo-Vac-R01 dose). 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 NCT06026774.

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 11 Sep 2023.

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