Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610227
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
A Study of the RNA Tumor Vaccine Targeting MICAB in Patients with Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Study to Evaluate the Safety Tolerability Preliminary Efficacy and Immunogenicity of the Novel RNA Tumor Vaccine Targeting MICAB Stress Proteins in Patients with Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label single-arm study to evaluate the safety and efficacy of multiple doses of SapRNA-MICAB Tumor Vaccine in patients with advanced solid tumors Eligible patients will receive the monotherapy with SapRNA-MICAB Tumor Vaccine which will be administered by intramuscular injection on Day 1 Day 14 and Day 28 respectively Follow-up visits will be performed as scheduled after the end of treatment
Detailed Description:
This is an open-label single-arm study to evaluate the safety and efficacy of multiple doses of SapRNA-MICAB Tumor Vaccine in patients with advanced solid tumors The primary study objective is to evaluate the safety tolerability and efficacy of a single dose of SapRNA-MICAB Tumor Vaccine in patients Eligible patients will receive the monotherapy with SapRNA-MICAB Tumor Vaccine which will be administered by intramuscular injection on Day 1 Day 14 and Day 28 respectively Follow-up visits will be performed as scheduled after the end of treatment The patients will be followed up until disease progression occurrence of intolerable toxicity initiation of a new antitumor therapy withdrawal of informed consent loss to follow-up death or any other protocol-specified conditions for which the treatment should be discontinued whichever earlier Throughout the study the safety after multiple doses will be evaluated as per the schedule of activities Endpoints like objective response rate ORR disease control rate DCR and progression-free survival PFS will be evaluated as per the RECIST v11 by the investigator After discontinuation or completion of the study treatment the end of treatment visit safety follow-up visit 6 months after end of the last dose and survival follow-up visit will be performed for the patients
The dose escalation and tolerability study is proposed to be conducted in the two dose groups of 5106 and 5107 active nanoparticles The patients will receive the treatment at a fixed dose in the study The dose escalation will be performed with reference to the 33 design during the dose-limiting toxicity DLT observation period with 3 patients enrolled first and observed for DLTs from Day 1 to Day 35 If none of the first 3 patients experience DLTs the study will proceed to the next higher dose level if 23 patients experience DLTs the study will be stopped if 13 patients experiences DLTs additional 3 patients will be enrolled if 16 patients experiences DLTs the study will proceed to the next higher dose level otherwise the study will be stopped
The dose escalation and tolerability study is proposed to be conducted in the two dose groups of 5106 and 5107 active nanoparticles The patients will receive the treatment at a fixed dose in the study The dose escalation will be performed with reference to the 33 design during the dose-limiting toxicity DLT observation period with 3 patients enrolled first and observed for DLTs from Day 1 to Day 35 If none of the first 3 patients experience DLTs the study will proceed to the next higher dose level if 23 patients experience DLTs the study will be stopped if 13 patients experiences DLTs additional 3 patients will be enrolled if 16 patients experiences DLTs the study will proceed to the next higher dose level otherwise the study will be stopped
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None