A Study of M701 (EpCAM and CD3) in Malignant Ascites

NCT04501744 | Completed Phase 1 FDA Drug

• 1 other identifier: M70101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malignant Ascites; Cancer

Outcome Measures

Primary Outcomes (2)

• MTD

  Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug in each cohort.

  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.

  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

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

• Maximum observed concentration (Cmax) of M701

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

• Minimum observed concentration (Cmin) of M701

  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

  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)

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

Study Arms (1)

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.

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

Interventions

Cohort 1 of M701 DRUG

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.

M701

Cohort 2 of M701 DRUG

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.

M701

Cohort 3 of M701 DRUG

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.

M701

Cohort 4 of M701 DRUG

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.

M701

Cohort 5 of M701 DRUG

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.

M701

Cohort 6 of M701 DRUG

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.

M701

Cohort 7 of M701 DRUG

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.

M701

Eligibility Criteria

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

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Wuhan YZY Biopharma Co., Ltd.: lead

Study Sites (2)

The 307th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 100000, China

Location

Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jianming Xu

  307 Hospital of PLA

  PRINCIPAL INVESTIGATOR

• Shixuan Wang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: August 6, 2020
• Study Start: September 30, 2018
• Primary Completion: February 28, 2022
• Study Completion: September 30, 2022
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)