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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsFemaleSuzhou Suncadia Biopharmaceuticals Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up. 2. Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor. 3. At least one measurable lesion conforming to RECIST v1.1. 4. ECOG PS score: 0-1. 5. Expected survival โ‰ฅ 12 weeks. 6. 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. Exclusion Criteria: 1. With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis. 2. Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled. 3. Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment. 4. With hypertension and cannot be well controlled by antihypertensive drug treatment. 5. Accompanied by poorly controlled or serious cardiovascular diseases. 6. Subjects with serious infection within 1 month before the first medication. 7. Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation. 8. There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.
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What it tests

  • SHR-A1811
  • Carboplatin
  • Bevacizumab
  • Oxaliplatin for Injection
  • Paclitaxel injection
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Where

1 site
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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