An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.

• Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.

• At least one measurable lesion conforming to RECIST v1.1.

• ECOG PS score: 0-1.

• Expected survival ≥ 12 weeks.

• Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.

Locations
Other Locations
China
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Shuni Wang
shuni.wang@hengrui.com
+86-0518-81220121
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2026-07
Participants
Target number of participants: 150
Treatments
Experimental: Treatment group
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov

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