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RecruitingNCT06828354Updated Apr 20, 2026

A Study of SHR-A1811 in Subjects With Ovarian Cancer

A Phase 3 interventional study of SHR-A1811 and Paclitaxel Injection in Ovarian Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Recruiting at 2 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.

02

Conditions studied

  • Ovarian Cancer

Browse trials for

03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 300 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    SHR-A1811 group

    Drug: SHR-A1811

  • Active comparator
    Chemotherapy group

    Drug: Paclitaxel Injection · Drug: Doxorubicin Hydrochloride Liposome Injection · Drug: Gemcitabine Hydrochloride for Injection · Drug: Topotecan Hydrochloride for Injection

Interventions

  • DrugSHR-A1811

    SHR-A1811.

  • DrugPaclitaxel Injection

    Paclitaxel Injection.

  • DrugDoxorubicin Hydrochloride Liposome Injection

    Doxorubicin Hydrochloride Liposome Injection.

  • DrugGemcitabine Hydrochloride for Injection

    Gemcitabine Hydrochloride for Injection.

  • DrugTopotecan Hydrochloride for Injection

    Topotecan Hydrochloride for Injection.

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: From day 1 to 10 months.

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: From day 1 to 12 months.

  2. Disease control rate (DCR)

    Time frame: From day 1 to 12 months.

  3. Duration of response (DOR)

    Time frame: From day 1 to 12 months.

  4. Overall survival (OS)

    Time frame: From day 1 to 12 months.

  5. Response rate (RR)

    Time frame: From day 1 to 12 months.

  6. Adverse events (AEs)

    Time frame: From day 1 to 40 days after the last dose.

07

Study locations

2 of 2 sites recruiting
  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
    • Ding Ma · Contact · ding_ma2022@163.com · 027-83663821
    • Ding Ma · Principal investigator
    • Qinglei Gao · Principal investigator
    Recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    • Beihua Kong · Contact · kongbeihua@sdu.edu.cn · 18653199168
    • Beihua Kong · Principal investigator
    • Kun Song · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06828354
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Feb 14, 2025
Start date
Mar 13, 2025
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 20, 2026

Study contacts

Yuanchao Wang
Contact
yuanchao.wang@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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