Ovarian CancerPhase 3NCT06828354
A Study of SHR-A1811 in Subjects With Ovarian Cancer
A Phase 3 study testing SHR-A1811, Paclitaxel Injection and Doxorubicin Hydrochloride Liposome Injection in people with Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- SHR-A1811, Paclitaxel Injection and Doxorubicin Hydrochloride Liposome Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 13 Mar 2025to Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined the study and signed the Informed consent forms (ICF).
- Measurable disease, as defined by RECIST v1.1.
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
Who cannot join
- Symptomatic, untreated or active central nervous system metastases.
- Have uncontrolled or severe cardiovascular disease.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
- Severe infections prior to initiation of study treatment.
- Patients with active tuberculosis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Beihua Kong, 18653199168, kongbeihua@sdu.edu.cn
Beihua Kong
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ding Ma, 027-83663821, ding_ma2022@163.com
Ding Ma
About this study
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
This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- SHR-A1811, Paclitaxel Injection, Doxorubicin Hydrochloride Liposome Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
SHR-A1811.
Paclitaxel InjectionDrug
Paclitaxel Injection.
Doxorubicin Hydrochloride Liposome InjectionDrug
Doxorubicin Hydrochloride Liposome Injection.
Gemcitabine Hydrochloride for InjectionDrug
Gemcitabine Hydrochloride for Injection.
Topotecan Hydrochloride for InjectionDrug
Topotecan Hydrochloride for Injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 group | Experimental | Not described Receives: Drug: SHR-A1811 |
| Chemotherapy group | Active comparator | Not described Receives: Drug: Paclitaxel Injection; Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Topotecan Hydrochloride for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: From day 1 to 10 months.
Secondary outcomes (6)
Objective response rate (ORR)
Measured: From day 1 to 12 months.
Disease control rate (DCR)
Measured: From day 1 to 12 months.
Duration of response (DOR)
Measured: From day 1 to 12 months.
Overall survival (OS)
Measured: From day 1 to 12 months.
Response rate (RR)
Measured: From day 1 to 12 months.
Adverse events (AEs)
Measured: From day 1 to 40 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start13 Mar 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828354
- Sponsor's protocol ID
- SHR-A1811-315
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided