Evaluation of the Safety, Tolerability and Efficacy of iNeo-Vac-R01, an Individualized mRNA Therapeutic Technology Based on Tumor Neoantigens, for Adjuvant Treatment in Patients With Biliary Malignant Tumors After Radical Resection

NCT07368803 | Recruiting Phase 1

• 1 other identifier: 2025-2714-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the safety of iNeo-Vac-R01, an individualized mRNA therapeutic technology based on tumor neoantigens, for the adjuvant treatment of patients with biliary malignant tumors after radical resection.

Conditions

Biliary Malignant Tumors

Outcome Measures

Primary Outcomes (1)

• Dose for Safety and Tolerability Evaluation

  Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, the number of subjects with adverse events and/or dose-limiting toxicities will be counted as indicators for evaluating the safety and tolerability dose of iNeo-Vac-R01 Injection. The safety data collection visit will be conducted at 21 days after the last treatment administration.

  21 days after last iNeo-Vac-R01 dose

Secondary Outcomes (2)

• Overall Survival (OS)

  3 years after first dose of iNeo-Vac-R01

• Relapse-Free Survival (RFS)

  3 years after first dose of iNeo-Vac-R01

Study Arms (1)

Participant Group

EXPERIMENTAL

Personalized mRNA Vaccine iNeo-Vac-R01

Biological: iNeo-Vac-R01

Interventions

iNeo-Vac-R01 BIOLOGICAL

IH injection

Participant Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, \>/= 18 years old and \</= 75 years old；
• Biliary malignant tumors confirmed by histopathological or cytological examination that are eligible for radical resection；

You may not qualify if:

• Expected survival \>/= 6 months.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 \~ 1；
• Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 2 puncture tissues with a tumor purity of ≥ 50% required for puncture samples and at least 0.5cm of tissue required for surgical samples. Alternatively, the original gene sequencing data required for tumor neoantigen analysis can be provided, including full exon sequencing data of tumor tissue, transcriptome sequencing data, and full exon sequencing data of peripheral blood；
• 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.
• Able to comply with the study protocol and follow-up procedures.
• Voluntarily participate in the study and sign the informed consent form. If a subject is unable to read the informed consent form (e.g., illiterate subjects), a witness shall be present to observe the informed consent process and sign the informed consent form on their behalf.
• 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 with symptomatic or untreated central nervous system metastases, except those underwent complete resection and/or radiotherapy and proven to be stable or improved (confirmed to be stable or improved for at least 4 weeks before the first dose of iNeo-Vac-R01 by CT or MRI, with no evidence of brain edema and no need for glucocorticoids or anticonvulsants.

Sponsors & Collaborators

• Yifan Wang: lead
• Hangzhou Neoantigen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

Central Study Contacts

Yifan Wang

CONTACT

0086-0571-86006605; anwyf@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician，Director，Principal Investigator

Model Details: Interventional

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)