Clinical trial NCT06751485: JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Primary Peritoneal
Fallopian Tube Cancers
Keywords: JSKN003-306
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-30
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
timeFrame: Up to approximately 22 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 22 months
measure: Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1
timeFrame: Up to approximately 22 months
measure: Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1
timeFrame: Up to approximately 22 months
measure: Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1
timeFrame: Up to approximately 22 months
measure: PFS evaluated by the Investigator as per RECIST 1.1
timeFrame: Up to approximately 22 months
measure: ORR evaluated by the Investigator as per RECIST 1.1
timeFrame: Up to approximately 22 months
measure: DoR evaluated by the Investigator as per RECIST 1.1
timeFrame: Up to approximately 22 months
measure: DCR evaluated by the Investigator as per RECIST 1.1
timeFrame: Up to approximately 22 months
measure: CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria
timeFrame: Up to approximately 22 months
measure: Number and Severity of Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 22 months
Other outcomes:
Locations:
Study officials:
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