Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT07150767
Status:
WITHDRAWN
Last Update Posted:
2025-12-02
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer
Sponsor:
Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Organization:
Study Overview
Official Title:
A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The applicant voluntarily withdrew the case
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A clinical study to explore the safety, tolerability, and efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) combined with neoadjuvant treatment for locally advanced breast cancer.This study is a single-arm, open-label, single-center dose-escalation and expansion trial.
Detailed Description:
Three study drug dose groups were preset, namely 5×10\^10VP、2×10\^11VP and 5×10\^11VP and the "3+ 3" dose escalation method was adopted according to the principle of dose escalation and the sequential principle from low to high.In order to protect the safety of subjects, in theory, in order to protect the safety of subjects, the second subject can be enrolled at least 2 weeks after the administration of the first subject in each dose group at least 2 weeks after administration in the DLT observation phase of the same dose group. The DLT observation period for each subject is 21 days after the first dose, and the next dose escalation can only be entered after the last subject in each dose group completes the DLT observation period. At least 3 subjects were enrolled in each dose group, and each subject received only one corresponding dose.
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?: