Evaluating SHR-A1811 for Ovarian Cancer Treatment
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
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 |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Wuhan, Hubei and 1 other locations) |
| Trial ID | NCT06828354 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with measurable ovarian cancer and an ECOG performance status of 0 or 1.
Not a fit: Patients with untreated central nervous system metastases or severe cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with ovarian cancer.
How similar studies have performed: Other studies have shown promise with similar approaches in treating ovarian cancer, but the specific efficacy of SHR-A1811 is still being evaluated.
Eligibility criteria
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 this trial is running
Wuhan, Hubei and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.