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

NCT05383703 | Completed Phase 1 DMC

• 1 other identifier: MNC-168-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability indexes

  The safety is evaluated by The National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE）V5.0.

  2 years

Secondary Outcomes (3)

• pharmacokinetic index

  2 years

• pharmacokinetic indexes

  2 years

• Efficacy evaluation indexes

  2 years

Study Arms (1)

Treatment of MNC-168 enteric-coated capsules as a single oral drug

EXPERIMENTAL

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.

Drug: Treatment of MNC-168 enteric-coated capsules as a single oral drug

Interventions

Treatment of MNC-168 enteric-coated capsules as a single oral drug 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.

Also known as: Therapy of Live bacteria MNC-168

Treatment of MNC-168 enteric-coated capsules as a single oral drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects are known (including suspected) allergic to the active ingredient MNC-168 or its excipients, or have an allergic constitution (excluding mild asymptomatic seasonal allergies);
• Subjects have difficulty swallowing or do not tolerate venipuncture or have a history of needle and blood sickness;
• Toxic reactions from prior antineoplastic therapy have not returned to grade 1 or below (Grade \> 1 based on CTCAE 5.0, except for toxicity such as alopecia, which in the judgment of the investigator is not a safety risk);
• Subjects have bleeding tendencies or are on thrombolytic or anticoagulant therapy.
• Subjects have received immunosuppressive drugs within 14 days before signing informed consent, except in the following cases:
• Intranasal, inhalation, topical steroid or topical steroid injection (such as intra-articular injection); 5.2 Systemic corticosteroid therapy with prednisone or its equivalent physiological dose not more than 10 mg/day; 5.3 Use of steroids as prophylactic drugs for allergic reactions (such as pretreatment before computed tomography \[CT\]).
• Subjects have received an allogeneic tissue/solid organ transplant;
• Subjects develop spinal cord compression, brain metastases or meningeal metastases, excluding those who do not need steroid therapy after surgery, whole brain radiotherapy or stereotactic radiosurgery, and whose disease is stable for ≥ 8 weeks and/or ≥ 4 weeks before the first administration;
• Subjects have had a cerebrovascular accident or a history of transient ischemic attack within 6 months prior to signing the informed consent form;
• Subjects require systemic antibacterial, antiviral or antifungal therapy for any uncontrolled active infection at the time of signing the informed consent and/or within 1 week prior to Cycle 1 Day 1 (C1D1); and subjects have received a course of systemic antibiotics within 2 weeks prior to C1D1;
• Subjects have a history of other primary malignancies within 5 years prior to the investigational therapy, with the following exceptions: radically treated malignancies that have not recurred, such as cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma;
• Subjects have active gastrointestinal diseases or other diseases that may significantly affect the absorption, distribution, metabolism or excretion of MNC-168;
• Subjects have a clear history of neurological or psychiatric disorders (including epilepsy and dementia);
• Subjects have received chemotherapy, radiotherapy or biological anticancer therapy, herbal therapy with antitumor effects, and palliative local radiotherapy within 2 weeks prior to the first dose;
• Subjects have taken live biotherapeutic products (LBPs), prebiotic foods and/or beverages and/or supplements (e.g., yogurt) within 1 week prior to the first dose or require regular doses of LBPs, prebiotic foods or supplements during the study period;

Sponsors & Collaborators

• Moon (Guangzhou) Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 20, 2022
• Study Start: October 28, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 4, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-04

Locations

CN (1)