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This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment cohort 1 | Experimental |
| |
| Treatment cohort 2 | Experimental |
| |
| Treatment cohort 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 | Drug | SHR-A1811 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade≥3 drug-related adverse events (TRAEs). | Up to 3 years. | |
| Grade≥3 drug-related serious adverse events (TRAEs). | Up to 3 years. | |
| Objective response rate (ORR). | Up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR). | Up to 3 years. | |
| Disease control rate (DCR). | Up to 3 years. | |
| Progression-free survival (PFS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na An | Contact | +86-0518-82342973 | na.an@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Adebelimab injection | Drug | Adebelimab injection. |
|
| Bevacizumab injection | Drug | Bevacizumab injection. |
|
| SHR-8068 | Drug | SHR-8068 injection. |
|
| Cisplatin injection | Drug | Cisplatin injection. |
|
| Carboplatin injection | Drug | Carboplatin injection. |
|
| Up to 3 years. |
| Overall survival (OS). | Up to 3 years. |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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