NCT03662815

Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Malignant Tumor

Safety, Tolerability and Partial Efficacy Study of a Personalized Neoantigen Cancer Vaccine inTreating Patients With Advanced Malignant Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a new type of cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced malignant tumor. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients with advanced malignant cancer, so as to provide a new personalized therapeutic strategy for advanced pancreatic cancer 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

Type	Name	Description
BIOLOGICAL	iNeo-Vac-P01	Neoantigen peptides
OTHER	GM-CSF	immune adjuvant

Timeline

• Start date: 2018-02-07
• Primary completion: 2021-05-20
• Completion: 2022-12-30
• First posted: 2018-09-07
• Last updated: 2021-11-16

Locations

1 site across 1 country: China