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Not yet recruiting NCT06751485

JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

Phase III Interventional Ovarian Cancer Primary Peritoneal Fallopian Tube Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JSKN003, Doxorubicin, Paclitaxel, Topotecan.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancers. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Drug JSKN003
    Experimental drug
  • Drug Doxorubicin
    Active Comparator
  • Drug Paclitaxel
    Active Comparator
  • Drug Topotecan
    Active Comparator

Primary outcome measures

  • Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1 [Time frame: Up to approximately 22 months]
Secondary outcome measures (10)
  • Overall Survival (OS) [Time frame: Up to approximately 22 months]
  • Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1 [Time frame: Up to approximately 22 months]
  • Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1 [Time frame: Up to approximately 22 months]
  • Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1 [Time frame: Up to approximately 22 months]
  • PFS evaluated by the Investigator as per RECIST 1.1 [Time frame: Up to approximately 22 months]
  • ORR evaluated by the Investigator as per RECIST 1.1 [Time frame: Up to approximately 22 months]
  • DoR evaluated by the Investigator as per RECIST 1.1 [Time frame: Up to approximately 22 months]
  • DCR evaluated by the Investigator as per RECIST 1.1 [Time frame: Up to approximately 22 months]
  • CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria [Time frame: Up to approximately 22 months]
  • Number and Severity of Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to approximately 22 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06751485 · JSKN003-306

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗