Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms

NCT06026800 | Recruiting Phase 1

• 1 other identifier: SRRSH2023-755-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 in combination with first-line treatment in subjects with advanced digestive system neoplasms.

Conditions

Digestive System Neoplasms

Keywords

iNeo-Vac-R01; Personalized mRNA Vaccine; Neoantigen; Digestive System Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  21 days after last iNeo-Vac-R01 dose

Secondary Outcomes (8)

• Overall Survival (OS)

  3 years after first dose of iNeo-Vac-R01

• Objective Response Rate (ORR)

  3 years after first dose of iNeo-Vac-R01

• Disease Control Rate (DCR)

  3 years after first dose of iNeo-Vac-R01

• Duration of Response (DOR)

  3 years after first dose of iNeo-Vac-R01

• Progression Free Survival (PFS)

  3 years after first dose of iNeo-Vac-R01

Study Arms (1)

Personalized mRNA Vaccine iNeo-Vac-R01 with standard first-line treatment

EXPERIMENTAL

Subjects will receive at least 4 cycles of standard first-line treatment according to Chinese Society of Clinical Oncology (CSCO) clinical guidelines. 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.

Biological: iNeo-Vac-R01

Interventions

iNeo-Vac-R01 BIOLOGICAL

Personalized mRNA vaccine encoding neoantigen, IH injection

Personalized mRNA Vaccine iNeo-Vac-R01 with standard first-line treatment

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, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.

You may not qualify if:

• Expected survival \>/= 6 months.
• 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.
• 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.
• 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.
• Subjects who have an active infection or uncontrollable infection requiring systemic treatment, including fungi, bacteria, viruses, or other infections; subjects with active tuberculosis;

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: 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

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Central Study Contacts

Xiujun Cai, MD

CONTACT

0086-0571-86006605; caixiujunzju@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of Sir Run Run Shaw Hospital

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 7, 2023
• Study Start: September 8, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

CN (1)