NCT06828354 A Study of SHR-A1811 in Subjects With Ovarian Cancer
| NCT ID | NCT06828354 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-03-13 |
| Primary Completion | 2027-05 |
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 300 participants in total. It began in 2025-03-13 with a primary completion date of 2027-05.
⚠ 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 is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.
Eligibility Criteria
Inclusion Criteria: 1. The subjects voluntarily joined the study and signed the Informed consent forms (ICF). 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks. Exclusion Criteria: 1. Symptomatic, untreated or active central nervous system metastases. 2. Have uncontrolled or severe cardiovascular disease. 3. With any active autoimmune disease or history of autoimmune disease. 4. Patients with active hepatitis B or hepatitis C. 5. Severe infections prior to initiation of study treatment. 6. Patients with active tuberculosis.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06828354 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, 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 NCT06828354 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 300 participants.
Is NCT06828354 currently recruiting?
Yes, NCT06828354 is actively recruiting participants. Contact the research team at yuanchao.wang@hengrui.com for enrollment information.
Where is the NCT06828354 trial being conducted?
This trial is being conducted at Wuhan, China, Jinan, China.
Who is sponsoring the NCT06828354 clinical trial?
NCT06828354 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 300 participants.
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