Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Multicenter, Randomized, Open-label Phase III Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Innovent Biologics (Suzhou) Co. Ltd.
450 participants
Mar 17, 2025
INTERVENTIONAL
Conditions
Summary
This is a multiregional, multicenter, randomized, open-label, phase III study to compare the efficacy, safety, and tolerability of IBI354 monotherapy with investigator's choice of chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan) in patients with HER2-expressing, platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Participants with advanced ovarian, primary peritoneal, fallopian tube cancer who have failed or are intolerant to first-line or more platinum-based chemotherapy will be randomly assigned in a 2:1 ratio to two treatment arms: Experimental Arm: IBI354 monotherapy arm, 12 mg/kg IBI354 on Day 1 of each 3-week cycle; Control Arm: Investigator's choice chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan)
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
intravenous infusion of 12 mg/kg on Day 1 of each 3-week treatment cycle
paclitaxel:- Usage and dosage: 80 mg/m2 administered as an intravenous infusion on Day 1 of each weekly treatment cycle。 Gemcitabine:Usage and dosage: intravenous infusion at 1000 mg/m2 on Days 1, 8 of each 3-week treatment cycle。 Liposomal doxorubicin:Usage and dosage: intravenous infusion of 40 mg/m2 on Day 1 of each 4-week treatment cycle
Locations(1)
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NCT06834672