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Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer. | Clinical Trials | Clareo Health

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Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.

NCT06888648•Zhejiang University

View on ClinicalTrials.gov

Summary

This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•(1) Subjects who meet all the following entry criteria enter the pre-screening phase of the study:
•1. Voluntary signing of the informed consent form;
•2. Age: 18 and 75 years old, male or female;
•3. Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines;
•4. No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy.
•5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;
•6. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1);
•7. Can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis;
•8. Main organ function of heart, liver and kidney is normal:
•9. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age included premenopause and women within 2 years after menopause;
+10 more criteria

Exclusion Criteria

•Subjects will be excluded from this study if they meet any of the following criteria:
•1. Pancreatic cancer has central nervous system metastasis or meningeal metastasis;
•2. At the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except;
•3. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
•4. Patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy;
•5. Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis;
•6. Patients with positive human immunodeficiency virus (HIV) antibody, positive treponema pallidum for syphilis (TP) antibody, active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA result), active hepatitis B;
•7. Herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks);
•8. Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases considered unacceptable by the investigator;
•9. Previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness;
+3 more criteria

Locations (1)

First Affiliated Hospital of Zhejiang University Schlool of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

April 1, 2025

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2028

Last Updated

March 21, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer MetastaticPancreatic Cancer Non-resectable

Interventions

individualized anti-tumor new antigen iNeo-Vac-R01 injection

BIOLOGICAL

mFOLFIRINOX Treatment Regimen

DRUG

Sintilimab injection

DRUG

Contacts

Tingbo Liang, MD., PhD.

CONTACT

+8619941463683 liangtingbo@zju.edu.cn

Yiwen Chen, MD.

CONTACT

+8615088682641 yiwenchen0705@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

Inclusion Criteria

Exclusion Criteria

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