NCT05383703

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Moon (Guangzhou) Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
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. First, live fungi can directly or indirectly inhibit tumor growth or induce tumor cell apoptosis through their metabolites or surface proteins, and can also regulate the immune system, especially the tumor microenvironment, to play an antitumor function. Second, tumor immunotherapies exhibit different response levels in different populations, and live bacterial analogs derived from gut microbes may enhance the response to immunotherapy in weakly responding patients.

Timeline

• Start date: 2022-10-28
• Primary completion: 2024-07-01
• Completion: 2024-07-04
• First posted: 2022-05-20
• Last updated: 2025-07-02

Locations

1 site across 1 country: China