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Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors

NCT05359354 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-05-16

No results posted yet for this study

Summary

This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA personalized neoantigen tumor vaccine in the treatment of advanced solid tumors, including two phases: dose escalation and dose expansion. The main objective is to evaluate the safety and tolerability of personalized neoantigen tumor vaccine in subjects with advanced solid tumors, and secondary objective is to preliminarily evaluate the efficacy of personalized neoantigen tumor vaccine in subjects with advanced solid tumors. 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 will be performed in combination with PD-1 to further evaluate the efficacy and safety profile of personalized 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 determine if the subject is suitable to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors.

Dose escalation phase is the traditional 3 + 3 design,, 12-18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (3-6 subjects in each group). The low dose group will be enrolled first.

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

Conditions

Interventions

BIOLOGICAL

Personalized neoantigen tumor vaccine

Biological: neoantigen tumor vaccine with or without PD-1 In dose escalation phase, subjects will receive neoantigen tumor vaccine only. In dose expansion phase, subjects will receive neoantigen tumor vaccine combination with PD-1

Sponsors & Collaborators

  • NeoCura

    collaborator INDUSTRY

  • YueJuan Cheng

    lead OTHER

Principal Investigators

  • Chunmei Bai, Dr. · Peking Union Medical College Hospital

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
2022-09-01
Primary Completion
2025-09-30
Completion
2025-12-31

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 NCT05359354 on ClinicalTrials.gov