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NCT Number: NCT06828354

A Study of SHR-A1811 in Subjects With Ovarian Cancer

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

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-A1811

Drug

SHR-A1811.

Paclitaxel Injection

Drug

Paclitaxel Injection.

Doxorubicin hydrochloride liposome injection

Drug

Doxorubicin Hydrochloride Liposome Injection.

Gemcitabine Hydrochloride for Injection

Drug

Gemcitabine Hydrochloride for Injection.

topotecan hydrochloride for injection

Drug

Topotecan Hydrochloride for Injection.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanchao Wang

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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