MedTrace Logo

Clinical Study of a Personalized Neoantigen Cancer Vaccine Combined With Anti-PD-1 and RFA in Patients With Solid Tumors

NCT04864379 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-28

No results posted yet for this study

Summary

This research study is evaluating a new type of personalized neoantigen cancer vaccine（iNeo-Vac-P01）combined with anti-PD-1 antibody and radiofrequency ablation as a possible treatment for patients with advanced solid tumors. The primary objective of this trial is to evaluate safety, tolerability and immunogenicity of iNeo-Vac-P01 in combination with anti-PD-1 and radiofrequency ablation, so as to provide a new personalized therapeutic strategy for patients.

It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Conditions

  • Advanced Malignant Solid Tumor

Interventions

BIOLOGICAL

iNeo-Vac-P01

iNeo-Vac-P01: 300 mcg per peptide

OTHER

GM-CSF

GM-CSF: 40 mcg

DRUG

PD-1

PD-1: 200mg administered by intravenous infusion every 2 weeks.

PROCEDURE

RFA

Radiofrequency ablation surgery

Sponsors & Collaborators

  • Hangzhou Neoantigen Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Sir Run Run Shaw Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2025-08-03
Completion
2025-08-03

Countries

  • China

Study Locations

More Related Trials

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 NCT04864379 on ClinicalTrials.gov