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)
Participants have the ability to understand and give written informed consent Form (ICF) for participation in this trial, including all evaluations and procedures as specified by this protocol;
Female participants ≥ 18 years old;
Expected life time ≥ 12 weeks
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Endometrioid tumor, clear cell tumor, mucinous tumor, mesenchymal tumor, or contains any of the above components.
Low-grade or borderline tumor, or contains any of the above components.
Participation in any other interventional clinical study, except observational (non-interventional) study.
Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.
Parallel
IBI354
Drugintravenous infusion of 12 mg/kg on Day 1 of each 3-week treatment cycle
paclitaxel/Gemcitabine/Liposomal doxorubicin
Drugpaclitaxel：- 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
To compare the Progression-free survival (PFS) of IBI354 monotherapy versus investigator's choice of chemotherapy
PFS as evaluated per the RECIST v1.1 criteria
Overall Survival (OS)
Overall survival
Number of subjects with clinically significant changes in physical examination results
Numbers of subjects with adverse events
CA-125 response rate according to Gynecologic Cancer Intergroup (GCIG) criteria.
To compare the objective response rate (ORR) of IBI354 monotherapy versus investigator's choice of chemotherapy
ORR as evaluated per the RECIST v1.1 criteria
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