NCT06751485Not yet recruitingPhase 3
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
Jiangsu Alphamab Biopharmaceuticals Co., Ltd0 sites430 target enrollmentStarted: January 15, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 430
- Primary Endpoint
- Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
- •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 ≤
- •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.
Arms & Interventions
Experimental: Treatment group 1:JSKN003
Experimental
Drug: JSKN003 JSKN003 dose 1
Intervention: JSKN003 (Drug)
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy
Active Comparator
Drug: Doxorubicin Doxorubicin dose 2
Drug: Paclitaxel Paclitaxel dose 3
Drug: Topotecan Topotecan dose 4
Intervention: Doxorubicin (Drug)
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy
Active Comparator
Drug: Doxorubicin Doxorubicin dose 2
Drug: Paclitaxel Paclitaxel dose 3
Drug: Topotecan Topotecan dose 4
Intervention: Paclitaxel (Drug)
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy
Active Comparator
Drug: Doxorubicin Doxorubicin dose 2
Drug: Paclitaxel Paclitaxel dose 3
Drug: Topotecan Topotecan dose 4
Intervention: Topotecan (Drug)
Outcomes
Primary Outcomes
Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
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
Secondary Outcomes
- Overall Survival (OS)(Up to approximately 22 months)
- Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1(Up to approximately 22 months)
- Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1(Up to approximately 22 months)
- Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1(Up to approximately 22 months)
- PFS evaluated by the Investigator as per RECIST 1.1(Up to approximately 22 months)
- ORR evaluated by the Investigator as per RECIST 1.1(Up to approximately 22 months)
- DoR evaluated by the Investigator as per RECIST 1.1(Up to approximately 22 months)
- DCR evaluated by the Investigator as per RECIST 1.1(Up to approximately 22 months)
- CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria(Up to approximately 22 months)
- Number and Severity of Treatment-emergent Adverse Events (TEAEs)(Up to approximately 22 months)
Investigators
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