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NCT Number: NCT06751485

JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JSKN003

Drug

Experimental drug

Doxorubicin

Drug

Active Comparator

paclitaxel

Drug

Active Comparator

Topotecan

Drug

Active Comparator

Primary outcomes

  1. 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

  1. Overall Survival (OS)

    Time frame: 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

  2. Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1

    Time frame: Up to approximately 22 months

    ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)

  3. Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1

    Time frame: Up to approximately 22 months

    DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first

  4. Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1

    Time frame: Up to approximately 22 months

    DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)

  5. PFS evaluated by the Investigator 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

  6. ORR evaluated by the Investigator as per RECIST 1.1

    Time frame: Up to approximately 22 months

    ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)

  7. DoR evaluated by the Investigator as per RECIST 1.1

    Time frame: Up to approximately 22 months

    DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first

  8. DCR evaluated by the Investigator as per RECIST 1.1

    Time frame: Up to approximately 22 months

    DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)

  9. CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria

    Time frame: Up to approximately 22 months

    CA-125 Response Rate was assessed according to the GCIG criteria

  10. Number and Severity of Treatment-emergent Adverse Events (TEAEs)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lingying Wu, Doctor

CONTACT

[email protected]

8610-87788495

Sponsors and collaborators

Lead sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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