JSKN003
DrugExperimental drug
NCT Number: NCT06751485
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Experimental drug
Active Comparator
Active Comparator
Active Comparator
Time frame: Up to approximately 22 months
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Time frame: Up to approximately 22 months
OS was defined as the time from the date of first dose until the date of death from any cause
Time frame: Up to approximately 22 months
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 22 months
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Time frame: Up to approximately 22 months
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Time frame: Up to approximately 22 months
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Time frame: Up to approximately 22 months
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 22 months
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Time frame: Up to approximately 22 months
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Time frame: Up to approximately 22 months
CA-125 Response Rate was assessed according to the GCIG criteria
Time frame: Up to approximately 22 months
The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.
Contact information is provided by the study sponsor or research team.
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Industry
A Randomized, Open-Label, Parallel-Controlled, Multi-center Phase Ⅲ Study of JSKN003 Versus Investigator-Choice Chemotherapy for Platinum-Resistant, Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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