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

NCT06266091 | Completed Phase 2

• 1 other identifier: M70102
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Ascites

Outcome Measures

Primary Outcomes (1)

• Puncture-free survival, PuFS

  The time to the next puncture/drainage or death

  From the time of 4th dosing (Day 18) to the next puncture/drainage or death (up to 6 months)

Secondary Outcomes (9)

• objective response rate (ORR) of malignant ascites

  From the time of 4th dosing (Day 18) to the next puncture/drainage or death (up to 180 days)re/drainage or death (up to 6 months)

• Progression-free Survival, PFS

  From the time of first dosing (Day 1) until disease progression or toxicity intolerance or death (up to 6 months).

• Overall survival, OS

  From the time of first dosing (Day 1) until death (up to 6 months).

• Quality of Life, QoL

  From the time of first dosing (Day 1) until the EOT (up to 6 months).

• Safety profiles

  From the time of first dosing (Day 1) until one month after the EOT (up to 6 months).

Study Arms (2)

M701 group

EXPERIMENTAL

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.

Drug: M701

Control group

ACTIVE COMPARATOR

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.

Drug: paracentesis

Interventions

M701 DRUG

Intra-peritoneal infusion of M701 combined with system therapy

M701 group

paracentesis DRUG

paracentesis combined with system therapy

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign the written informed consent form.
• Histologically or pathologically confirmed epithelial malignancies, including advanced gastric cancer or colorectal cancer that has failed at least two lines of treatment, or platinum-resistant advanced ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma.
• Clinical diagnosis of malignant ascites with a moderate or higher amount of ascites. Moderate or higher is defined as having a volume of ascites ≥1L based on CT assessment or actual drainage of ≥1L.
• The time interval between the most recent anti-tumor treatment and the first dose of M701 must meet the following criteria:
• Intraperitoneal treatment: ≥2 weeks since the most recent intraperitoneal treatment.
• Adverse events (AEs) from previous treatments have recovered to grade ≤1 (excluding other AEs deemed by the investigator not to affect the safety of the study drug, such as hair loss).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. Estimated survival time ≥8 weeks.
• Organ function levels must meet the following requirements:
• Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L, platelets ≥80 × 10\^9/L, hemoglobin ≥8.5 g/dL, lymphocyte ratio (lymphocyte count/leukocyte count) ≥10% (without transfusion within 14 days).
• Liver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN (AST and ALT ≤5 times ULN allowed in the presence of liver metastasis).
• Serum albumin ≥28 g/L. Renal function: Serum creatinine ≤1.5 times ULN.

You may not qualify if:

• Patients who have previously received M701 or any antibody-based drugs targeting EpCAM and/or CD3 within the 4 months prior to the first dose.
• Patients with microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) colorectal cancer who have not previously received immunotherapy.
• Patients who have undergone major surgery within the 4 weeks prior to the first dose.
• Patients with extensive liver metastases (tumor volume occupying approximately \>70% of total liver volume).
• Active infections requiring intravenous antibiotics within 14 days before the first dose.
• Severe diarrhea (CTCAE grade ≥2).
• Severe respiratory distress requiring oxygen therapy.
• Active autoimmune diseases, except for the following conditions that are allowed for screening: type 1 diabetes, controlled hypothyroidism with replacement therapy only, skin diseases that do not require systemic treatment。
• Other severe medical conditions that may limit the patient's participation in the trial。
• Impaired cardiac function with New York Heart Association (NYHA) class 3 or 4.
• Occurrence of complete intestinal obstruction within 30 days before the first dose, or diagnosis of incomplete intestinal obstruction deemed unsuitable for participation in the trial based on symptoms and signs as determined by the investigator.
• Inability to adequately drain ascites due to objective reasons (including loculated ascites).
• Confirmed portal vein obstruction.
• History of immunodeficiency, including positive HIV test.
• Active hepatitis B virus infection, active hepatitis C virus infection, active syphilis, or positive HIV antibody.

Sponsors & Collaborators

• Wuhan YZY Biopharma Co., Ltd.: lead

Study Sites (1)

The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100141, China

Location

MeSH Terms

Interventions

Paracentesis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jianming Xu, MD

  The First Medical Center of Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 20, 2024
• Study Start: November 24, 2021
• Primary Completion: February 14, 2024
• Study Completion: August 1, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)