Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT07182435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Clinical Study of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced Solid Tumors
Sponsor:
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Organization:
Study Overview
Official Title:
A Phase 1 Clinical Trial of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced or Metastatic Solid Tumors Evaluating the Safety, Tolerability, and Efficacy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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 a Phase 1 clinical study investigating RH125 as monotherapy or in combination therapy in patients with locally advanced or metastatic solid tumors who failed standard treatment, or were intolerant to standard treatment, or declined standard treatment. The aim of the study is to evaluate the tolerability, safety, immunogenicity, and preliminary efficacy of RH125 monotherapy or combination with PD-1 blocker.
Detailed Description:
This study will be divided into monotherapy dose escalation and combination therapy dose escalation phases. Each phase requires the enrollment of 12-18 subjects, with a total of 24-36 subjects to be enrolled in the entire study. Both the monotherapy dose escalation and combination therapy dose escalation will involve 3 dose levels, which are 100 μg, 150 μg, and 200 μg respectively. A "3+3" design will be adopted, and the Dose-Limiting Toxicity (DLT) observation period will be 21 days for both phases.
Study Oversight
Has Oversight DMC:
False
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?: