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Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody

NCT06432296 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-05-11

No results posted yet for this study

Summary

A Randomized, Controlled, Multi-Center Phase III Clinical Study to Compare the Efficacy and Safety of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody (M701) for Intraperitoneal Injection to Paracentesis alone in Patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors.

Conditions

  • Malignant Ascites

Interventions

DRUG

M701

Intra-peritoneal infusion of M701 in experimental group (M701 group\_

PROCEDURE

paracentesis

Puncture and Draiange of ascites from the peritoneal cavity in both experimental group and control group

Sponsors & Collaborators

  • Wuhan YZY Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianming Xu, MD · The First Medical Center of Chinese PLA General Hospital

  • Yanqiao zhang, PhD · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2026-06-12
Completion
2026-12-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06432296 on ClinicalTrials.gov