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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.
Full description
To evaluate the safety and tolerability of multiple ascending doses of M701 administered intraperitoneally in patients with malignant ascites.
Enrollment
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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;
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.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
42 participants in 1 patient group
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Central trial contact
Xiong Wang
Data sourced from clinicaltrials.gov
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