Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancers
Conditions
Keywords
JSKN003-306
Brief summary
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.
Interventions
DRUGJSKN003
Experimental drug
DRUGDoxorubicin
Active Comparator
DRUGPaclitaxel
Active Comparator
DRUGTopotecan
Active Comparator
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To evaluate the efficacy and safety of JSKN003 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntary participation and written informed consent. * ≥18 years; * Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. * Confirmed platinum-resistant relapse. * According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline. * Expected survival of more than 3 months. * ECOG performance status score of 0 or 1. * Adequate organ function. * Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.
Exclusion criteria
* Primary platinum-refractory disease. * Active central nervous system metastases. * Uncontrolled pleural effusion. * Previous treatment with topoisomerase I inhibitor ADCs. * Other malignant tumors within 5 years. * Interstitial pneumonia/lung disease requiring systemic corticosteroids or suspected interstitial pneumonia/lung disease. * Uncontrolled comorbidities. * Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1. * History of allogeneic bone marrow or organ transplantation. * Allergic reactions or hypersensitivity to antibody drugs. * Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1 | Up to approximately 22 months | PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1 | Up to approximately 22 months | ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR) |
| Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1 | Up to approximately 22 months | DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first |
| Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1 | Up to approximately 22 months | DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD) |
| PFS evaluated by the Investigator as per RECIST 1.1 | Up to approximately 22 months | PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first |
| Overall Survival (OS) | 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 |
| DoR evaluated by the Investigator as per RECIST 1.1 | Up to approximately 22 months | DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first |
| DCR evaluated by the Investigator as per RECIST 1.1 | Up to approximately 22 months | DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD) |
| CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria | Up to approximately 22 months | CA-125 Response Rate was assessed according to the GCIG criteria |
| Number and Severity of Treatment-emergent Adverse Events (TEAEs) | 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. |
| ORR evaluated by the Investigator as per RECIST 1.1 | Up to approximately 22 months | ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR) |
Contacts
Primary ContactLingying Wu, Doctor
Outcome results
None listed