Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497010
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Brief Title:
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
Sponsor:
The Affiliated Hospital Of Guizhou Medical University
Organization:
The Affiliated Hospital Of Guizhou Medical University
Study Overview
Official Title:
An Open Label Prospective Exploratory Study to Assess the Safety and Efficacy of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Combination With PD-1 in Participants With Advanced Solid Tumor
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label prospective exploratory clinical study which is divided into two phases dose escalation phase Phase Ia and expansion phase Phase Ib After completing the dose-escalation phase Stage Ia 5-11 patients the investigator will select the dose group RP2D based on safety tolerability and preliminary immune-related characteristics and efficacy data and choose 2-3 advanced solid tumors to enter the expansion phase Stage Ib
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None