Evaluating SHR-A1811 for Gynaecological Cancers
Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies
This study is testing a new injectable treatment called SHR-A1811 to see if it can help people with advanced cervical, recurrent ovarian, and endometrial cancers feel better and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05896020 on ClinicalTrials.gov |
What this trial studies
This open-label, two-part study aims to assess the safety and efficacy of SHR-A1811, an injectable treatment, in patients with gynaecological malignancies. Participants will be monitored for measurable disease outcomes as defined by RECIST v1.1, and the study will include individuals with advanced cervical cancer, recurrent ovarian cancer, and endometrial cancer. The study will also evaluate the overall health and performance status of participants using the ECOG scale.
Who should consider this trial
Good fit: Ideal candidates are individuals with advanced cervical cancer, recurrent ovarian cancer, or endometrial cancer who meet specific health criteria.
Not a fit: Patients with active 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 therapeutic option for patients with difficult-to-treat gynaecological cancers.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating gynaecological malignancies with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The subjects voluntarily joined the study and signed the 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. 5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer. Exclusion Criteria: 1. Symptomatic, untreated or active central nervous system metastases. 2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc.. 3. Have uncontrolled or severe cardiovascular disease. 4. With any active autoimmune disease or history of autoimmune disease. 5. Patients with active hepatitis B or hepatitis C. 6. Severe infections within 28 days prior to initiation of study treatment. 7. Active tuberculosis within one year prior to initiation of study treatment.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Bo Li, Ph.D.
- Email: bo.li@hengrui.com
- Phone: +86 021-61053363
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.