NCT06394492 SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
| NCT ID | NCT06394492 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2024-05-10 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 440 participants in total. It began in 2024-05-10 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
Eligibility Criteria
Inclusion Criteria: 1. Voluntary participation and written informed consent. 2. 18 years and older, female. 3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 4. Patients must have platinum-resistant disease 5. Be able to provide fresh or archived tumour tissue. 6. At least one measurable lesion according to RECIST v1.1. 7. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 8. With a life expectancy ≥ 12 weeks. 9. Adequate bone marrow reserve and organ function. 10. Contraception is required during the trial. Exclusion Criteria: 1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 2. Previous or co-existing malignancies. 3. Current or History of ILD. 4. Clinical symptoms or diseases of the heart that are not well controlled. 5. Arterial/venous thrombosis events occurred before the first dose. 6. Grade ≥2 bleeding events of CTCAE occurred before the first dose. 7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose. 8. Patients with intestinal obstruction or parenteral nutrition before the first dose. 9. Serious infection before the first dose. 10. Active hepatitis B or active hepatitis C. 11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment. 12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload. 13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy. 14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921. 15. Other inappropriate situation considered by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06394492 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06394492 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 440 participants.
Is NCT06394492 currently recruiting?
Yes, NCT06394492 is actively recruiting participants. Contact the research team at shuni.wang@hengrui.com for enrollment information.
Where is the NCT06394492 trial being conducted?
This trial is being conducted at Beijing, China, Hangzhou, China.
Who is sponsoring the NCT06394492 clinical trial?
NCT06394492 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 440 participants.
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