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

PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

September 30, 2018

Primary Completion Date

February 28, 2022

Study Completion Date

September 30, 2022

Conditions
Malignant AscitesCancer
Interventions
DRUG

Cohort 1 of M701

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.

DRUG

Cohort 2 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.

DRUG

Cohort 3 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.

DRUG

Cohort 4 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.

DRUG

Cohort 5 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.

DRUG

Cohort 6 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.

DRUG

Cohort 7 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.

Trial Locations (2)

100000

The 307th Hospital of Chinese People's Liberation Army, Beijing

430000

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

All Listed Sponsors
lead

Wuhan YZY Biopharma Co., Ltd.

INDUSTRY

NCT04501744 - A Study of M701 (EpCAM and CD3) in Malignant Ascites | Biotech Hunter | Biotech Hunter