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This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1: SHR-1921 | Experimental |
| |
| Treatment group 2: SHR-1921 + carboplatin dose level 1 | Experimental |
| |
| Treatment group 3: SHR-1921 + carboplatin dose level 2 | Experimental |
| |
| Treatment group 4: platinum-based doublet chemotherapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1921 | Drug | SHR-1921 |
| |
| carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate Assessed by Investigator According to RECIST v1.1 | Screening up to study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year | |
| Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanchao Wang | Contact | 0518-81220278 | yuanchao.wang@hengrui.com |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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SHR-A1921 with or without Carboplatin compared with Investigator's Choice of Platinum-based Doublet Chemotherapy
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| Drug |
carboplatin AUC 4 |
|
| carboplatin | Drug | carboplatin AUC 5 |
|
| platinum-based doublet chemotherapy | Drug | platinum-based doublet chemotherapy |
|
| Progression-Free Survival (PFS) Assessed by Investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Overall Survival (OS) | Screening up to study completion, an average of 1 year |
| CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria | Screening up to study completion, an average of 1 year |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |