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This is an open label, multi-center, phase I/II study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701 plus Famitinib | Experimental | SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 | Drug | Intravenous (IV) on Day 1 of each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. | up to approximately 2 years (anticipated) |
| Measure | Description | Time Frame |
|---|---|---|
| DoR | Duration of Response per RECIST 1.1 | up to approximately 2 years (anticipated) |
| DCR | DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Yang, MD | Contact | +86-021-15705155017 | qing.yang@hengrui.com | |
| Yanbo Liu, MB | Contact | +86-021-18036614138 | yanbo.liu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Guangzhou Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
| C584390 | famitinib |
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| Famitinib | Drug | Famitinib, po, qd |
|
|
| up to approximately 2 years (anticipated) |
| PFS | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first. | up to approximately 2 years (anticipated) |
| OS | Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive. OS will be measured by the Method of Kaplan and Meier. | up to approximately 2 years (anticipated) |
| AEs | Number of participants with adverse events as assessed by CTCAE v5.0 | up to approximately 2 years (anticipated) |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |