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

NCT06026774 | Recruiting Phase 1

• 1 other identifier: SRRSH2023-755-03
• 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 with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.

Conditions

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 (6)

• Overall Survival (OS)

  3 years after first dose of iNeo-Vac-R01

• Recurrence Free Survival (RFS)

  3 years after first dose of iNeo-Vac-R01

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

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

• Neoantigen-specific T Cell Response [immunogenicity]

  12 months after first dose of iNeo-Vac-R01

• T Cell Subsets [immunogenicity]

  12 months after first dose of iNeo-Vac-R01

Study Arms (1)

iNeo-Vac-R01 in combination with standard adjuvant therapy

EXPERIMENTAL

Subjects 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.

Biological: iNeo-Vac-R01 in combination with standard adjuvant therapy

Interventions

iNeo-Vac-R01 in combination with standard adjuvant therapy BIOLOGICAL

Personalized mRNA vaccine encoding neoantigen, IH injection

iNeo-Vac-R01 in combination with standard adjuvant therapy

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:

• Subjects with any of the following digestive system neoplasms:
• a. Cholangiocarcinoma b. Pancreatic cancer c. Hepatocellular carcinoma d. Gastric cancer e. Colorectal carcinoma
• 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 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.
• 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.

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

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)