This is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of SYS6043 versus investigator's choice chemotherapy in participants with platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer.
This is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of SYS6043 versus investigator's choice chemotherapy in participants with platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer. Approximately 460 eligible participants will be enrolled in the study. Participants in the experimental group will receive SYS6043, administered on Day 1 of each cycle. Participants in the control group will receive investigator's choice chemotherapy: Liposomal doxorubicin 40 mg/m² every 28 days (Q4W), administered on Day 1 of each cycle; Paclitaxel 80 mg/m² every 28 days (Q4W), administered on Days 1, 8, 15, and 22 of each cycle; Topotecan 4 mg/m² every 28 days (Q4W), administered on Days 1, 8, and 15 of each cycle. Participants will continue to receive SYS6043 or investigator's choice chemotherapy until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). Tumor assessments based on RECIST v1.1, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (± 7 days, + 7days for the first tumor assessment after Screening) from Cycle 1 Day 1 (C1D1) for the first 36 weeks then every 12 weeks (± 7 days) until disease progression, death, the start of new anticancer therapy, or participant's withdrawal of consent (whichever occurs first). Participants who discontinue treatment prior to disease progression shall continue to undergo tumor assessment until the first occurrence of any of the following: imaging-confirmed disease progression, death, loss to follow-up, withdrawal from the trial by the participant or their legal representative, initiation of new anti-tumor therapy, or completion of the entire trial.Imaging frequency as before. All participants who discontinue SYS6043 or investigator's choice chemotherapy will be followed for survival every 2 months (± 7 days) until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (EOS) (whichever comes first). Additional survival follow-up calls may occur periodically, if needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
Participants in the experimental group will receive SYS6043, administered on Day 1 of each cycle.
Participants in the control group will receive investigator's choice chemotherapy: Liposomal doxorubicin 40 mg/m² every 28 days (Q4W), administered on Day 1 of each cycle; Paclitaxel 80 mg/m² every 28 days (Q4W), administered on Days 1, 8, 15, and 22 of each cycle; Topotecan 4 mg/m² every 28 days (Q4W), administered on Days 1, 8, and 15 of each cycle.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGProgression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.
Time frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 16 months.
Overall Survival
Time from randomization to the date of death due to any cause.
Time frame: From date of randomization to death due to any cause, up to approximately 39 months.
ORR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time frame: up to approximately 24 months.
DoR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time frame: up to approximately 24 months.
DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1.
Time frame: up to approximately 24 months.
PFS by the investigator based on RECIST v1.1.
Time frame: up to approximately 24 months.
ORR by the investigator based on RECIST v1.1.
Time frame: up to approximately 24 months.
DoR by the investigator based on RECIST v1.1.
Time frame: up to approximately 24 months.
DCR by the investigator based on RECIST v1.1.
Time frame: up to approximately 24 months.
CA-125 response rate assessed by the investigator.
The GCIG CA-125 response is defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.
Time frame: up to approximately 24 months.
Incidence of Adverse Events (AE) assessed by CTCAE 6.0.
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment assessed by CTCAE 6.0. The investigator assesses the relationship of each event to the use of study drug.
Time frame: up to approximately 39 months.
Number of Participants With Anti-Drug Antibodies (ADA).
Incidence, titer of anti-SYS6043 antibodies, and incidence of neutralizing antibodies (if applicable).
Time frame: up to approximately 39 months.
Serum concentrations of toxin-bound antibody of SYS6043.
Time frame: up to approximately 24 months.
Serum concentrations of total antibody of SYS6043.
Time frame: up to approximately 24 months.
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