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Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Gastric Cancer

NCT05227378 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-02-07

No results posted yet for this study

Summary

This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose.

Both the dose escalation phase and dose expansion phase include a screening period (Week -4 \~ Week -2), a baseline period (Week -1 \~ Day -1), a treatment period (Day 1 \~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 \~ Week 8) and the enhanced treatment period (Week 12 \~ Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12.

In the dose escalation phase, 18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (6 subjects in 100 μg, 6 subjects in 200 μg and 6 subjects in 400 μg). The low dose group was enrolled first, and the next dose group was started when the number of subjects met the requirements. If any subject withdrew early, the low dose group was given priority.

The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.

Conditions

Interventions

BIOLOGICAL

neoantigen tumor vaccine with or without PD-1/L1

personalized neoantigen tumor vaccine with or without PD-1/L1

Sponsors & Collaborators

  • NeoCura

    collaborator INDUSTRY

  • Shen Lin

    lead OTHER

Principal Investigators

  • LIN SHEN, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2025-03-31
Completion
2025-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227378 on ClinicalTrials.gov