Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 7:20 AM
Study NCT ID:
NCT05383703
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of MNC-168 Enteric-coated Capsule in the Treatment of Advanced Intestinal Solid Tumor
Sponsor:
Moon (Guangzhou) Biotechnology Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Clinical Study on Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of MNC-168 Enteric-coated Capsules in Patients With Advanced Malignant Solid Tumors
Status:
COMPLETED
Status Verified Date:
2025-04
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:
MNC-168
Brief Summary:
This study is a multicenter, open-label, dose-escalation Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of live bacterium MNC-168 as a single oral agent in subjects with advanced malignant solid tumors. To explore the changes of biomarkers and intestinal flora related to curative effect, mechanism of action, safety and/or pathological mechanism.
Detailed Description:
A total of four dose groups (0.25 × 10\^10 colony forming unit, 1 × 10\^10 colony forming unit, 5 × 10\^10 colony forming unit, and 12.5 × 10\^10 colony forming unit) are pre-designed for this study in patients with advanced malignant solid tumors, with three subjects in each dose group in a "3+3" dose escalation design.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: