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Malignant AscitesPhase 2NCT06266091

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

A Phase 2 study testing M701 and paracentesis in people with Malignant Ascites, run by Wuhan YZY Biopharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Ascites
What is being tested?
M701 and paracentesis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteChina
Study dates
24 Nov 2021to 1 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • Pregnant or lactating women.
  • Patients with fertility requirements during or within 6 months after treatment.
  • Known history of neurological or psychiatric disorders deemed by the investigator to affect cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100141

Other trials in China

About this study

Official title: 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.

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.

Read the detailed description

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.

Being tested
M701, paracentesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M701Drug

    Intra-peritoneal infusion of M701 combined with system therapy

  • paracentesisDrug

    paracentesis combined with system therapy

Study groups in NCT06266091
Study groupRoleWhat they receive
M701 groupExperimentalM701 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.
Receives: Drug: M701
Control groupActive comparatorPatients 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.
Receives: Drug: paracentesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Puncture-free survival, PuFS

    The time to the next puncture/drainage or death

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

Secondary outcomes (8)

  1. objective response rate (ORR) of malignant ascites

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

    Measured: 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)

  2. Progression-free Survival, PFS

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

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

  3. Overall survival, OS

    The time to death

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

  4. Safety profiles

    frequency, relationship and seriousness of adverse events

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

  5. Positive rate of ADA and Nab in serum

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

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

  6. The EpCAM expression in ascites

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

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

  7. Trough serum concentration (Ctrough)

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

    Measured: 6 months (anticipated)

  8. Peak serum concentration (Cmax)

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

    Measured: 6 months (anticipated)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start24 Nov 2021
  3. Primary completion14 Feb 2024
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06266091
Sponsor's protocol ID
M70102
Status last verified
Jun 2026
First submitted
23 Jan 2024
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing M701 and paracentesis in people with Malignant Ascites, run by Wuhan YZY Biopharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Puncture-free survival, PuFS (time frame: From the time of 4th dosing (Day 18) to the next puncture/drainage or death (up to 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06266091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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