Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510260, China
Location status: Recruiting
Location contact
Bingjia He
CONTACT
Zhenfeng Zhang, MD, PHD
PRINCIPAL_INVESTIGATOR
Zhenfeng Zhang, MD, PhD
CONTACT
NCT Number: NCT06195293
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Guangzhou, 510260, China
Location status: Recruiting
Bingjia He
CONTACT
Zhenfeng Zhang, MD, PHD
PRINCIPAL_INVESTIGATOR
Zhenfeng Zhang, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
Deliver neoantigen polypeptide vaccine into patients for anti-ancer therapy.
Time frame: Six months
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
Time frame: Six months
Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.
Contact information is provided by the study sponsor or research team.
Bingjia He, MD
CONTACT
Zhenfeng Zhang, MD, PhD
CONTACT
Second Affiliated Hospital of Guangzhou Medical University
Other
Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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