JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

Launched by JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD · Dec 25, 2024

Keywords

ClinConnect Summary

This clinical trial, called JSKN003, is studying a new treatment for women with certain types of ovarian cancer that have returned after previous therapy and are no longer responding to standard platinum-based treatments. The trial aims to compare the effectiveness and safety of the new drug, JSKN003, to the usual chemotherapy options that doctors would choose for these patients. The study is currently not recruiting participants yet, but it will focus on women aged 18 and older who have been diagnosed with relapsed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

To be eligible for the trial, participants must have measurable cancer that is resistant to platinum-based treatments and should expect to live for more than three months. They should also be in good health overall, with no serious other health issues that could interfere with the treatment. If someone joins the trial, they will receive either the new treatment or the standard chemotherapy and will be monitored closely throughout the study. It’s important for potential participants to be aware that they will need to agree to the study rules and attend regular check-ups.

Gender

FEMALE

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.