Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody (NCT06266091) | Clinical Trial Compass
CompletedPhase 2
Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody
China115 participantsStarted 2021-11-24
Plain-language summary
A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Able to understand and voluntarily sign the written informed consent form.
* Histologically or pathologically confirmed epithelial malignancies, including advanced gastric cancer or colorectal cancer that has failed at least two lines of treatment, or platinum-resistant advanced ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma.
* Clinical diagnosis of malignant ascites with a moderate or higher amount of ascites. Moderate or higher is defined as having a volume of ascites ≥1L based on CT assessment or actual drainage of ≥1L.
* The time interval between the most recent anti-tumor treatment and the first dose of M701 must meet the following criteria:
Intraperitoneal treatment: ≥2 weeks since the most recent intraperitoneal treatment.
* Adverse events (AEs) from previous treatments have recovered to grade ≤1 (excluding other AEs deemed by the investigator not to affect the safety of the study drug, such as hair loss).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. Estimated survival time ≥8 weeks.
* Organ function levels must meet the following requirements:
Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L, platelets ≥80 × 10\^9/L, hemoglobin ≥8.5 g/dL, lymphocyte ratio (lymphocyte count/leukocyte count) ≥10% (without transfusion within 14 days).
Liver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤…
What they're measuring
1
Puncture-free survival, PuFS
Timeframe: From the time of 4th dosing (Day 18) to the next puncture/drainage or death (up to 6 months)