NCT06751485Not yet recruitingPhase 3
JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer
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
Source: ClinicalTrials.gov · Last updated 31 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 430 (estimated)
- First submitted
- 25 Dec 2024
- Start date
- 15 Jan 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Diseases
- Ovarian cancer
- NCT number
- NCT06751485
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 430
- From 15 Jan 2025 to the primary completion date, 30 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with topoisomerase I inhibitor ADCs.
- Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.
Other illness
- Primary platinum-refractory disease.
- Other malignant tumors within 5 years.
- Interstitial pneumonia/lung disease requiring systemic corticosteroids or suspected interstitial pneumonia/lung disease.
- 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.
Other
- Active central nervous system metastases.
- Uncontrolled pleural effusion.
- Uncontrolled comorbidities.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.