Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ascites

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

M701 will be administered via intra-peritoneal infusion following sufficient drainage of malignant ascites. The treatment regimen consists of a leading dose of 50μg on Day 1, followed by three infusions of the full dose of 400 μg M701 on Days 4, 11, and 18. If well tolerated, patients will continue to receive M701 infusions every 2 weeks as maintenance treatment. Additionally, these patients will receive systemic therapy as determined by the investigator.

Patients in the control group will undergo paracentesis on Day 1 and Day 18. If necessary, they may receive additional paracentesis during this period. Additionally, these patients will receive systemic therapy as determined by the investigator.

Intra-peritoneal infusion of M701 combined with system therapy

M701

paracentesis combined with system therapy

paracentesis

Jianming Xu, MD

A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy.

The phase II study is a controlled, open-label trial designed to assess the effectiveness and safety of M701 intra-peritoneal infusion for controlling malignant ascites in patients with gastrointestinal and ovarian cancer who are also receiving systemic therapy.

A total of 80 patients with malignant ascites caused by gastrointestinal or ovarian cancer will be randomly assigned to two treatment arms in a 1:1 ratio. These patients must have experienced disease progression or intolerance after receiving at least two lines of systemic therapy. Both treatment arms will receive the systemic therapy, but the test arm will additionally receive M701 intra-peritoneal infusion, while the control arm will undergo paracentesis only.

The primary endpoint of the study will be the puncture-free survival, which evaluates the efficacy of M701 in controlling malignant ascites. Secondary endpoints include the objective response rate (ORR) of malignant ascites, progression-free survival (PFS), overall survival (OS), quality of life (QOL), and safety profiles. The number of EpCAM-positive cells in the malignant ascites will be measured using flow cytometry before and after treatment with M701.

Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody

A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 Combined With Systemic Therapy in Patients With Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer.

The time to the next puncture/drainage or death

The change of precentage of malignant ascites volume from the baseline by the image evaluation

The time to disease progression assessed by the imaging evaluation or toxicity or death

Using the QLQ-C30 Scale to score the quality of life at every visit, which includes 3 parts: global health status(2-14, higher is better), funtional status(16-64, lower is better), symptom scale(12-48, lower is better),

frequency, relationship and seriousness of adverse events

The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) in the serum during the study

Measure the count of EpCAM postive cells in the ascites before and after M701 treatment

The lowest concentration of M701 in the serum in one treatment cycle

The highest concentration of M701 in the serum in one treatment cycle

Wuhan YZY Biopharma Co., Ltd.

M701 will be administered via intra-peritoneal infusion following sufficient drainage of malignant ascites.

The treatment regimen consists of a leading dose of 50μg on Day 1, followed by three infusions of the full dose of 400 μg M701 on Days 4, 11, and 18. If well tolerated, patients will continue to receive M701 infusions every 2 weeks as maintenance treatment.Additionally, these patients will receive systemic therapy as determined by the investigator.

Intra-peritoneal infusion of M701 in experimental group (M701 group_

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

Shaoyi Huang, PhD

Xiong Wang, MS

Rongrui Liu, MD

Yanqiao Zhang, PhD

Yanqiao zhang, PhD

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.

The phase III study is a controlled, open-label trial designed to assess the effectiveness and safety of M701 intra-peritoneal infusion for controlling malignant ascites in patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors who are also receiving systemic therapy.

A total of 270 patients with malignant ascites caused by Malignant Ascites Caused by Advanced Epithelial Solid Tumors will be randomly assigned to two treatment arms in a 2:1 ratio. These patients must have experienced disease progression or intolerance after receiving at least two lines of systemic therapy.

Both treatment arms will receive the systemic therapy as per the investigator's instructions. The test arm will receive paracentesis and intra-peritoneal infusion of M701, while the control arm will receive paracentesis alone.

The primary endpoint of the study is the puncture-free survival, which evaluates the efficacy of M701 in controlling malignant ascites. Secondary endpoints include the overall survival (OS),Time to next puncture (TTNP), Patient-reported outcome (PRO) score, 6-month survival rate,1-month and 2-month puncture-free survival rate, safety profiles,and Anti-m701 antibody (ADA) and Neutralizing antibody (NAb).

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

A Randomized, Controlled, Multi-Center Phase III Clinical Study to Evaluate the Efficacy and Safety of M701 for Intraperitoneal Injection in Patients With Malignant Ascites Caused by Advanced Epithelial Solid Tumors

Time from the end of drainage of C1V4 ascites to the beginning of the next drainage (as the time of drainage)

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 V3.0) was used to evaluate the quality of life of the subjects. This questionnaire is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. For the first 28 questions, the score is from 1-4, the lower score represents the better quality. For the last 2 quesionts, the score is from 1-7, the higher score represents the better health and quality of life.

Incidence of Treatment-Emergent Adverse Events, ≥grade 3 Treatment-Emergent Adverse Events, Serious Adverse Events and Treatment-Related Adverse Events.

Defined as the time from the end of C1V4 ascites drainage to the next drainage (based on the time of puncture) or the time of death is recorded as the PuFS.

Time from randomization to death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody	NCT06266091	Malignant Ascit...	M701 paracentesis	18 Years - 75 Years	Wuhan YZY Biopharma Co., Ltd.
Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody	NCT06432296	Malignant Ascit...	M701 paracentesis	18 Years - 75 Years	Wuhan YZY Biopharma Co., Ltd.

Spots Global Cancer Trial Database for m701

Every month we try and update this database with for m701 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for m701

Every month we try and update this database with for m701 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for m701 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.