Clinical Study of MNC-168 Enteric-coated Capsule in the Treatment of Advanced Intestinal Solid Tumor

Phase 1

• Conditions: Advanced Malignant Solid Tumors
• Interventions: Drug: Treatment of MNC-168 enteric-coated capsules as a single oral drug

• Registration Number: NCT05383703
• Lead Sponsor: Moon (Guangzhou) Biotechnology Co., Ltd.

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 Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-20
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-02
• Study Start: 2022-06-30
• Primary Completion: 2024-04-10
• Study Completion: 2024-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of MNC-168 enteric-coated capsules as a single oral drug	Treatment of MNC-168 enteric-coated capsules as a single oral drug	Treatment of live bacterium MNC-168 as a single oral agent as a single oral drug in subjects with advanced malignant solid tumors. The dosage increased in different stages. Each phase was administered once a day for three weeks.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability indexes	2 years	The safety is evaluated by The National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE）V5.0.

Secondary Outcome Measures

Name	Time	Method
pharmacokinetic index	2 years	Total colony forming unit(CFU) of Enterococcus lactis excreted in stools, expressed as raw values and log10 conversion
pharmacokinetic indexes	2 years	CFU/g of Enterococcus lactis excreted in stools, expressed as raw values and log10 conversion
Efficacy evaluation indexes	2 years	Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 are adopted for solid tumor efficacy evaluation in this study. The guidelines describe a standard method for measuring solid tumors and defining objective changes in tumor size in adult and pediatric tumor clinical trials.