Evaluating SHR-A1811 for Ovarian Cancer Treatment
Official title: An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Run by Jiangsu HengRui Medicine Co., Ltd. · NCT06828354 · Data updated 2026-11-12
This study is testing if a new drug called SHR-A1811 can help improve treatment for people with ovarian cancer when used alongside standard chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Wuhan, Hubei and 1 other locations) |
| Status | Recruiting |
| Started | March 13, 2025 |
| Main results expected | May 2027 |
| Study ends | December 2027 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT06828354 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with measurable ovarian cancer and an ECOG performance status of 0 or 1.
✕Probably not a fit
Patients with untreated central nervous system metastases or severe cardiovascular disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label Phase 3 study aims to assess the safety and efficacy of SHR-A1811 in patients diagnosed with ovarian cancer. Participants will receive SHR-A1811 along with standard chemotherapy agents such as Paclitaxel, Doxorubicin, Gemcitabine, and Topotecan. The study will include subjects with measurable disease and will monitor their response to treatment over time. The goal is to determine if SHR-A1811 can improve outcomes for these patients compared to existing therapies.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with ovarian cancer.
How similar studies have gone: Other studies have shown promise with similar approaches in treating ovarian cancer, but the specific efficacy of SHR-A1811 is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting -
Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Yuanchao Wang
- Email: yuanchao.wang@hengrui.com
- Phone: 0518-82342973
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.