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drugset / Trial / NCT05383703

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

NCT05383703 ↗

Phase 1 Completed 12 enrolled Moon (Guangzhou) Biotechnology Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-10-28
Primary completion
2024-07-01
Completion
2024-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject MNC-168 Other / unclassified 0.25 unknown Oral
Subject MNC-168 Other / unclassified 1 unknown Oral
Subject MNC-168 Other / unclassified 5 unknown Oral
Subject MNC-168 Other / unclassified 12.5 unknown Oral

Indications

cancer