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
Overview
- Phase
- Phase 1
- Intervention
- Treatment of MNC-168 enteric-coated capsules as a single oral drug
- Conditions
- Advanced Malignant Solid Tumors
- Sponsor
- Moon (Guangzhou) Biotechnology Co., Ltd.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Safety and tolerability indexes
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Treatment of MNC-168 enteric-coated capsules as a single oral drug
Outcomes
Primary Outcomes
Safety and tolerability indexes
Time Frame: 2 years
The safety is evaluated by The National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE）V5.0.
Secondary Outcomes
- pharmacokinetic index(2 years)
- pharmacokinetic indexes(2 years)
- Efficacy evaluation indexes(2 years)