Symptoms and General Pathology

All Conditions

Ascites

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Muromonab-CD3

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.

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 1 of M701

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 2 of M701

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 3 of M701

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 4 of M701

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 5 of M701

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 6 of M701

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.

Cohort 7 of M701

Xiong Wang

Jianming Xu

Shixuan Wang

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.

To evaluate the safety and tolerability of multiple ascending doses of M701 administered intraperitoneally in patients with malignant ascites.

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

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

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

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.

The endpoints for assessment of PK of M701 include serum concentrations of M701 at different timepoints after M701 administration.

The immunogenicity of M701 will be collected by testing the antibody titer of the neutralizing antibody.

The immunogenicity of M701 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

As tumor marker, expression levels of CEA will be tested in each study site.

As tumor marker, expression levels of CA125 will be tested in each study site.

As tumor marker, expression levels of CA72-4 will be tested in each study site.

As tumor marker, expression levels of CA19-9 will be tested in each study site.

As tumor marker, expression levels of AFP will be tested in each study site.

The levels of pharmacodynamic cytokines will be determined at the PD central laboratory.

Lymphocyte subsets will be determined at the PD central laboratory.

Ascites volume will be collected before each dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of M701 (EpCAM and CD3) in Malignant Ascites	NCT04501744	Malignant Ascit... Cancer	Cohort 1 of M70... Cohort 2 of M70... Cohort 3 of M70... Cohort 4 of M70... Cohort 5 of M70... Cohort 6 of M70... Cohort 7 of M70...	18 Years -	Wuhan YZY Biopharma Co., Ltd.
A Study of M701 (EpCAM and CD3) in Malignant Ascites	NCT04501744	Malignant Ascit... Cancer	Cohort 1 of M70... Cohort 2 of M70... Cohort 3 of M70... Cohort 4 of M70... Cohort 5 of M70... Cohort 6 of M70... Cohort 7 of M70...	18 Years -	Wuhan YZY Biopharma Co., Ltd.

Spots Global Cancer Trial Database for cohort 6 of m701