Malignant AscitesPhase 1NCT04501744
A Study of M701 (EpCAM and CD3) in Malignant Ascites
A Phase 1 study testing Cohort 1 of M701, Cohort 2 of M701 and Cohort 3 of M701 in people with Malignant Ascites and Cancer, run by Wuhan YZY Biopharma Co., Ltd. at 2 sites in China.
Trial summary
This study is to investigate the safety, tolerability, PK, PD and immunogenicity of multiple ascending doses of M701 administered intraperitoneally to patients with malignant ascites caused by advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Ascites, Cancer
- What is being tested?
- Cohort 1 of M701, Cohort 2 of M701 and Cohort 3 of M701
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesChina
- Study dates
- 30 Sep 2018to 30 Sep 2022
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged > 18 years;
- Histologically- or cytologically-confirmed advanced solid tumors;
- Patients who require therapeutic paracentesis, defined as at least 1 therapeutic paracentesis (e.g., to relieve abdominal pressure and discomfort) during 4 weeks prior to the baseline paracentesis;
- Patients who have failed to standard treatment, or who have no standard treatment available that may confer clinical benefit;
- EpCAM+ tumor cells in ascites fluid;
- Patients who have received anti-tumor therapy including chemotherapy, hormone therapy, radiotherapy (except local radiotherapy for pain relief) ≥ 2 weeks or received immunotherapy, biological agents ≥ 3 weeks prior to the first dose of study drug;
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- Patients who have recovered from any toxic reaction to previous medications (Grade 0 or 1 based on NCI-CTCAE v5.0);
- Patients with an ECOG Performance Status score (PS) 0-3;
- Patients with a life expectancy > 8 weeks;
- Organ function levels must meet the following requirements:
- Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 ×10^9/L, platelet count ≥ 80 ×10^9/L, hemoglobin ≥ 9.0 g/dL (without blood transfusion within14 days of the first dose of study drug); Liver: bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 x ULN ( ≤ 5 x ULN in case of liver metastases); Kidney: serum creatinine ≤1.5 x ULN and estimated glomerular filtration rate (eGFR) ≥ 50 ml/min;
- Patients must understand and voluntarily sign the informed consent form.
Who cannot join
- Known to have a history of allergy to the active ingredients of M701; or with a definite history of drug allergy or specific allergy (asthma, rubella, eczema dermatitis);
- Known or suspected hypersensitivity to M701 or similar antibodies;
- Extensive liver metastases (> 70% organ volume comprises malignancy);
- Uncontrolled active infection (CTCAE ≥ Grade 2);
- Serious diarrhea (CTCAE ≥ Grade 2);
- Serious dyspnea requiring oxygen therapy;
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- History of auto-immune diseases (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, serious psoriasis, rheumatoid arthritis);
- History of acute or chronic pancreatitis;
- Other serious diseases that may prevent patients participation in this trial (such as uncontrolled diabetes mellitus, severe gastrointestinal disorders);
- Cardiac insufficiency, NYHA class III or IV;
- Intestinal obstruction that occurred within 30 days prior to the first dose of study drug;
- Non-drainable ascites;
- Confirmed portal vein obstruction;
- History of immunodeficiency, including positive HIV test;
- Active hepatitis B virus infection or hepatitis C virus infection, positive syphilis antibody test and positive HIV antibody test;
- Pregnant or breastfeeding woman;
- Plan to conceive within six months;
- Previous confirmed history of neurological or mental disorders, including epilepsy and dementia;
- Have received a clinical study active drug treatment within 1 month prior to the first dose of study drug;
- Those that are deemed ineligible for this clinical trial by study personnel.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100000
Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability and PK/PD of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody Via Intraperitoneal Infusion in Malignant Ascites
This study is to investigate the safety, tolerability, PK, PD and immunogenicity of multiple ascending doses of M701 administered intraperitoneally to patients with malignant ascites caused by advanced solid tumors.
Read the detailed description
To evaluate the safety and tolerability of multiple ascending doses of M701 administered intraperitoneally in patients with malignant ascites.
- Conditions
- Malignant Ascites, Cancer
- Being tested
- Cohort 1 of M701, Cohort 2 of M701, Cohort 3 of M701, Cohort 4 of M701, Cohort 5 of M701
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 of M701Drug
Patients in Cohort 1 will receive 4 escalating doses (2, 5, 10 and 25 μg) of M701 on Days 1, 8, 15 and 22. The maintenance dose during extended treatment period is 25 μg.
Cohort 2 of M701Drug
Patients in Cohort 2 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 25 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.
Cohort 3 of M701Drug
Patients in Cohort 3 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.
Cohort 4 of M701Drug
Patients in Cohort 4 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 200 μg.
Cohort 5 of M701Drug
Patients in Cohort 5 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 150 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.
Cohort 6 of M701Drug
Patients in Cohort 6 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 200 μg, and the maintenance dose during core treatment period and extended treatment period is 400 μg.
Cohort 7 of M701Drug
Patients in Cohort 7 will receive a starting doseon Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 250 μg, and the maintenance dose during core treatment period and extended treatment period is 500 μg.
| Study group | Role | What they receive |
|---|---|---|
| M701 | Experimental | Patients will undergo a 2-week screening period and a 4-week core treatment period, and eligible patients who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance. Receives: Drug: Cohort 1 of M701; Drug: Cohort 2 of M701; Drug: Cohort 3 of M701; Drug: Cohort 4 of M701; Drug: Cohort 5 of M701; Drug: Cohort 6 of M701; Drug: Cohort 7 of M701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug in each cohort.
Measured: From the time of the first dose (Day 1) until the forth dosing (Day 28)
Incidence of AEs
Incidence and severity of AEs, including but not limited to vital signs, physical examination, laboratory tests. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.
Measured: From the start of administration to the end of the study or 28 days after the administration is stopped (up to 6 months and 28 days)
Secondary outcomes (13)
Area under the curve (AUC) of M701
The endpoints for assessment of PK of M701 include serum concentrations of M701 at different timepoints after M701 administration.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Maximum observed concentration (Cmax) of M701
The endpoints for assessment of PK of M701 include serum concentrations of M701 at different timepoints after M701 administration.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Minimum observed concentration (Cmin) of M701
The endpoints for assessment of PK of M701 include serum concentrations of M701 at different timepoints after M701 administration.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
The antibody titer of the neutralizing antibody
The immunogenicity of M701 will be collected by testing the antibody titer of the neutralizing antibody.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of M701 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Expression levels of CEA
As tumor marker, expression levels of CEA will be tested in each study site.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Expression levels of CA125
As tumor marker, expression levels of CA125 will be tested in each study site.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Expression levels of CA72-4
As tumor marker, expression levels of CA72-4 will be tested in each study site.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Expression levels of CA19-9
As tumor marker, expression levels of CA19-9 will be tested in each study site.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Expression levels of AFP
As tumor marker, expression levels of AFP will be tested in each study site.
Measured: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Cytokines
The levels of pharmacodynamic cytokines will be determined at the PD central laboratory.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Counts of Lymphocyte subsets
Lymphocyte subsets will be determined at the PD central laboratory.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Ascites volume
Ascites volume will be collected before each dose.
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start30 Sep 2018
- Primary completion28 Feb 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan YZY Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianming Xu, Principal investigator, 307 Hospital of PLAShixuan Wang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501744
- Sponsor's protocol ID
- M70101
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2020
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability and PK/PD of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody Via Intraperitoneal Infusion in Malignant Ascites
- ClinicalTrials.gov ID
- NCT04501744
- Acronym / sponsor ID
- M70101
- Conditions
- Malignant Ascites, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wuhan YZY Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the safety, tolerability, PK, PD and immunogenicity of multiple ascending doses of M701 administered intraperitoneally to patients with malignant ascites caused by advanced solid tumors.
Detailed description
To evaluate the safety and tolerability of multiple ascending doses of M701 administered intraperitoneally in patients with malignant ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M701 | Experimental | Drug: Cohort 1 of M701, Drug: Cohort 2 of M701, Drug: Cohort 3 of M701, Drug: Cohort 4 of M701, Drug: Cohort 5 of M701, Drug: Cohort 6 of M701, Drug: Cohort 7 of M701Patients will undergo a 2-week screening period and a 4-week core treatment period, and eligible patients who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females, aged > 18 years;
- Histologically- or cytologically-confirmed advanced solid tumors;
- Patients who require therapeutic paracentesis, defined as at least 1 therapeutic paracentesis (e.g., to relieve abdominal pressure and discomfort) during 4 weeks prior to the baseline paracentesis;
- Patients who have failed to standard treatment, or who have no standard treatment available that may confer clinical benefit;
- EpCAM+ tumor cells in ascites fluid;
Key exclusion criteria (20 listed)
- Known to have a history of allergy to the active ingredients of M701; or with a definite history of drug allergy or specific allergy (asthma, rubella, eczema dermatitis);
- Known or suspected hypersensitivity to M701 or similar antibodies;
- Extensive liver metastases (> 70% organ volume comprises malignancy);
- Uncontrolled active infection (CTCAE ≥ Grade 2);
- Serious diarrhea (CTCAE ≥ Grade 2);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1 of M701Patients in Cohort 1 will receive 4 escalating doses (2, 5, 10 and 25 μg) of M701 on Days 1, 8, 15 and 22. The maintenance dose during extended treatment period is 25 μg. | Drug | M701 |
| Cohort 2 of M701Patients in Cohort 2 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 25 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg. | Drug | M701 |
| Cohort 3 of M701Patients in Cohort 3 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg. | Drug | M701 |
| Cohort 4 of M701Patients in Cohort 4 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 200 μg. | Drug | M701 |
| Cohort 5 of M701Patients in Cohort 5 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 150 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg. | Drug | M701 |
| Cohort 6 of M701Patients in Cohort 6 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 200 μg, and the maintenance dose during core treatment period and extended treatment period is 400 μg. | Drug | M701 |
| Cohort 7 of M701Patients in Cohort 7 will receive a starting doseon Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 250 μg, and the maintenance dose during core treatment period and extended treatment period is 500 μg. | Drug | M701 |
Primary outcome
MTD
Time frame: From the time of the first dose (Day 1) until the forth dosing (Day 28)
Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug in each cohort.
Incidence of AEs
Time frame: From the start of administration to the end of the study or 28 days after the administration is stopped (up to 6 months and 28 days)
Incidence and severity of AEs, including but not limited to vital signs, physical examination, laboratory tests. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.
13 secondary outcomes
Area under the curve (AUC) of M701
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Maximum observed concentration (Cmax) of M701
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Minimum observed concentration (Cmin) of M701
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
The antibody titer of the neutralizing antibody
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Expression levels of CEA
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Expression levels of CA125
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Expression levels of CA72-4
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Expression levels of CA19-9
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Expression levels of AFP
Time frame: From the time of screening period until disease progression or toxicity intolerance (up to 6 months and 14 days).
Cytokines
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Counts of Lymphocyte subsets
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Ascites volume
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianming Xu principal investigator
307 Hospital of PLA
Shixuan Wang principal investigator
Tongji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cohort 1 of M701, Cohort 2 of M701 and Cohort 3 of M701 in people with Malignant Ascites and Cancer, run by Wuhan YZY Biopharma Co., Ltd. at 2 sites 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 12 inclusion and 20 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
MTD (time frame: From the time of the first dose (Day 1) until the forth dosing (Day 28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2025.