Clinical trial · Interventional
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
NCT06751485CI-TRIAL-00084213not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancers | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| JSKN003 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Treatment group 1:JSKN003
- description
- Drug: JSKN003 JSKN003 dose 1
- interventionNames
- Drug: JSKN003
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Treatment group 2: Investigator's choice of chemotherapy
- description
- Drug: Doxorubicin Doxorubicin dose 2 Drug: Paclitaxel Paclitaxel dose 3 Drug: Topotecan Topotecan dose 4
- interventionNames
- Drug: Doxorubicin
- Drug: Paclitaxel
- Drug: Topotecan
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.