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

COMPLETEDPHASE1

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

NCT05383703•Moon (Guangzhou) Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must meet all of the following criteria to be included in this study:
•1. They voluntarily participate in the clinical study; fully understand, are informed about this study and sign the Informed Consent Form; are willing to follow and have the ability to complete all trial procedures.
•2. Subjects are required to meet the following criteria: they must be subjects with histologically or cytologically confirmed advanced malignant solid tumors who do not respond to, or are intolerant to, or reject standard treatment, or receive no effective treatment;
•3. ≥18 years old, both male and female;
•4. They have an expected survival of ≥ 3 months;
•5. Their performance status score is 0 to 1 according to the Eastern Cooperative Oncology Group (ECOG) criteria;
•6. There is at least one measurable or assessable lesion according to RECIST V1.1;
•7. The organ function must meet the following requirements:
•7.1 No serious hematopoietic abnormalities (no blood transfusion, and no use of blood products, granulocyte colony-stimulating factors, platelet-stimulating factors or other hematopoietic growth factors for correction within 14 days prior to the screening lab test): hemoglobin (HGB) ≥ 90 g/L, neutrophil count (ANC) ≥ 1.5 × 109 /L, platelet count (PLT) ≥ 100 × 109 /L; 7.2 Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN) (subjects without liver metastases) or ≤ 5 × ULN (subjects with liver metastases); serum total bilirubin ≤ 1.5 × ULN, total bilirubin levels in subjects with Gilbert's syndrome ≤ 3.0 × ULN; 7.3 Coagulation function: prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time (APTT) ≤ 1.5 × ULN; 7.4 Renal function: Creatinine (Cr) ≤ 1.5 × ULN and serum creatinine clearance rate ≥ 50 ml/min (see Appendix 1);
•8. Eligible subjects (male or female) of childbearing potential must agree to take a medically approved contraceptive measure (e.g., intrauterine device, pill, or condom) during the trial and for 3 months after the last dose; female subjects of childbearing potential must have a negative pregnancy test result during the screening period and must be non-lactating; See Appendix 2 for specific contraception measures.
+1 more criteria

Exclusion Criteria

•1. 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);
•2. Subjects have difficulty swallowing or do not tolerate venipuncture or have a history of needle and blood sickness;
•3. 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);
•4. Subjects have bleeding tendencies or are on thrombolytic or anticoagulant therapy.
•5. Subjects have received immunosuppressive drugs within 14 days before signing informed consent, except in the following cases:
•5.1 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 \[CT\]).
•6. Subjects have received an allogeneic tissue/solid organ transplant;
•7. 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;
•8. Subjects have had a cerebrovascular accident or a history of transient ischemic attack within 6 months prior to signing the informed consent form;
•9. 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;
+16 more criteria

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

October 28, 2022

Primary Completion Date

July 1, 2024

Completion Date

July 4, 2024

Last Updated

July 2, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Malignant Solid Tumors

Interventions

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

DRUG

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RECRUITINGPHASE1

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NOT_YET_RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors

A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors

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