Actively Recruiting
A Clinical Study to Assess Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine iNeo-Vac-R01 in Advanced Digestive System Neoplasms
Led by Sir Run Run Shaw Hospital · Updated on 2023-09-11
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
S
Sir Run Run Shaw Hospital
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and effectiveness of a personalized mRNA vaccine called iNeo-Vac-R01 in people with advanced digestive system cancers. This phase 1 clinical study focuses on patients whose cancer has progressed after standard treatments or who cannot tolerate or choose not to receive standard therapies. The study includes a dose escalation phase followed by a dose expansion phase to find the best dose for further testing. Participants will receive iNeo-Vac-R01 through a hypodermic injection under the skin on the first day of each 21-day cycle, for up to 9 cycles. During the dose escalation phase, groups of 3 to 6 subjects will receive increasing doses of 50, 100, and 150 micrograms to determine the optimal dose. Then, this chosen dose will be used in the dose expansion phase to further evaluate the vaccine. Throughout the study, researchers will monitor participants closely for adverse events, dose-limiting toxicities, and treatment feasibility. They will also assess survival rates, tumor response, disease control, immune responses, and other health measures over several years after treatment begins. Participants will undergo tumor tissue collection or provide existing genetic data, blood tests, heart function tests, and clinical evaluations to support these assessments and ensure safety and adherence to the protocol.
CONDITIONS
Brief Title
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years who can understand and sign informed consent and comply with protocol requirements
- Histologically or cytologically confirmed advanced digestive system neoplasms with measurable disease by RECIST v1.1
- Disease progression after standard treatment or intolerance or unwillingness to receive standard treatment
- Expected survival of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Ability to provide sufficient tumor tissue samples or original gene sequencing data for neoantigen analysis
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiographic evaluation
- Adequate organ function including neutrophil count, platelet count, hemoglobin, liver and kidney function within specified limits
- Women of childbearing potential must have a negative pregnancy test and agree to contraception during treatment
- Men must agree to abstinence or contraception during treatment
You will not qualify if you...
- Cancer requiring anti-tumor treatment within 5 years prior to enrollment, except certain early-stage or treated cancers
- Major surgery, traumatic injury, or untreated wounds within 2 weeks before first vaccine dose
- No new antigens available for immunotherapy based on sequencing data
- Prior or planned bone marrow or organ transplantation, or other anti-tumor treatments within 2 weeks before first dose
- Use of immunosuppressants or systemic glucocorticoids within 7 days before first dose, except low-dose exceptions
- Symptomatic or untreated central nervous system metastases unless stable for at least 4 weeks
- Receipt or planned receipt of other vaccines within specified time frames around study treatment
- Active or uncontrolled infections including tuberculosis
- Positive for hepatitis B or C, HIV, or syphilis antibodies with active infection
- Autoimmune diseases or immune deficiencies requiring immunosuppressive drugs, except some controlled conditions
- Significant heart or cerebrovascular diseases, poor blood pressure control, or severe ECG abnormalities
- Severe respiratory diseases or impaired lung function
- Moderate to severe ascites or uncontrolled pleural or pericardial effusions
- Drug abuse or psychological/social factors affecting consent or study participation
- History of allergies to immunotherapy or vaccines
- Investigators' judgment of unsuitability for enrollment or study completion
- Vulnerable groups including mental illness, cognitive impairment, critical illness, minors, pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 27 weeks
Participants receive the personalized mRNA vaccine iNeo-Vac-R01 by hypodermic injection on Day 1 of each 21-day cycle for up to 9 cycles.
Up to 9 visits (in-person) every 3 weeks
Duration - Up to 3 years
Participants are monitored for safety, feasibility, and efficacy outcomes after completing the vaccine treatment.
Periodic visits for assessments up to 3 years after first dose
Trial Site Locations
Total: 1 location
1
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiujun Cai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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