A Study of SHR-A1811 in Subjects With Ovarian Cancer

Last updated: March 21, 2025
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Pelvic Cancer

Vaginal Cancer

Ovarian Cysts

Treatment

Paclitaxel Injection

Gemcitabine Hydrochloride for Injection

SHR-A1811

Clinical Study ID

NCT06828354
SHR-A1811-315
  • Ages 18-75
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 300
Treatment Group(s): 5
Primary Treatment: Paclitaxel Injection
Phase: 3
Study Start date:
March 13, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

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