Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 to 75 Women only

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

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexWomen only
Enrollment300 (estimated)
SponsorJiangsu HengRui Medicine Co., Ltd.
Industry-sponsored
Locations2 sites (Wuhan, Hubei and 1 other locations)
StatusRecruiting
StartedMarch 13, 2025
Main results expectedMay 2027
Study endsDecember 2027
Registry record updatedApril 20, 2026
Trial IDNCT06828354 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.