JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer
NCT ID: NCT06751485
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
430 participants
INTERVENTIONAL
2025-01-15
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: Treatment group 1:JSKN003
Drug: JSKN003 JSKN003 dose 1
JSKN003
Experimental drug
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy
Drug: Doxorubicin Doxorubicin dose 2
Drug: Paclitaxel Paclitaxel dose 3
Drug: Topotecan Topotecan dose 4
Doxorubicin
Active Comparator
Paclitaxel
Active Comparator
Topotecan
Active Comparator
Interventions
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JSKN003
Experimental drug
Doxorubicin
Active Comparator
Paclitaxel
Active Comparator
Topotecan
Active Comparator
Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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.
18 Years
FEMALE
No
Sponsors
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Jiangsu Alphamab Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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JSKN003-306
Identifier Type: -
Identifier Source: org_study_id