RecruitingPhase 1Phase 2NCT06840002

A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

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


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

150 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called SHR-A1811 (an antibody-drug conjugate that delivers chemotherapy directly to cancer cells) in combination with standard chemotherapy for patients with advanced breast cancer. The study focuses on patients whose cancer expresses high levels of HER2 or has not responded to prior treatments. **You may be eligible if...** - You have advanced breast cancer with measurable tumors on scans - Your cancer has specific characteristics (e.g., HER2-positive or other subtypes being enrolled) - Your general health score (ECOG) is 0 or 1 - Your expected survival is at least 12 weeks - You are willing and able to use contraception **You may NOT be eligible if...** - You have untreated brain metastases or cancer spread to the lining of the brain - You have significant fluid around your lungs, heart, or abdomen that is uncontrolled - You have serious heart, liver, or lung conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A1811

SHR-A1811.

DRUGCarboplatin

Carboplatin.

DRUGBevacizumab

Bevacizumab.

DRUGOxaliplatin for Injection

Oxaliplatin for injection.

DRUGPaclitaxel injection

Paclitaxel injection.

DRUGDoxorubicin hydrochloride liposome injection

Doxorubicin hydrochloride liposome injetction.

DRUGAdebrelimab Injection

Adebrelimab injection.


Locations(1)

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

Wuhan, Hubei, China

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NCT06840002


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