CompletedPhase 1

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

China35 participantsStarted 2018-09-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

MTD

Timeframe: From the time of the first dose (Day 1) until the forth dosing (Day 28)

Incidence of AEs

Timeframe: 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)

Trial details

NCT IDNCT04501744

SponsorWuhan YZY Biopharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-28

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