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| Name | Class |
|---|---|
| Akeso Tiancheng, Inc | OTHER |
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This is a multicenter, single-arm open-label, phase II study to evaluate the anti-tumor activity, safety, PK and immunogenicity of AK105 (Anti-PD1 antibody) in patients with metastatic nasopharyngeal carcinoma who have progressed after at least 2 prior lines of systemic chemotherapy (of which one of them must be platinum-based chemotherapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK105 | Experimental | Subjects receive AK105 200 mg intravenously (IV) once every 2 weeks (Q2W) until progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK105 | Biological | intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by IRRC per RECIST v1.1 for anti-tumor activity in the Full Analysis Set (FAS) population | ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) as assessed by IRRC and investigator | PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first). | up to 2 years |
| Disease control rate (DCR) as assessed by IRRC and investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chaosu Hu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| FuDan University Shanghai Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35833116 | Derived | Huang Z, Pang X, Zhong T, Qu T, Chen N, Ma S, He X, Xia D, Wang M, Xia M, Li B. Penpulimab, an Fc-Engineered IgG1 Anti-PD-1 Antibody, With Improved Efficacy and Low Incidence of Immune-Related Adverse Events. Front Immunol. 2022 Jun 27;13:924542. doi: 10.3389/fimmu.2022.924542. eCollection 2022. |
| Label | URL |
|---|---|
| Related Info | View source |
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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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DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1. |
| up to 2 years |
| Duration of response (DoR) as assessed by IRRC and investigator | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. | up to 2 years |
| Overall survival (OS) | OS is defined as the time from the date of randomization to death from any cause. | up to 2 years |
| Incidence and severity of treatment-emergent adverse events (TEAEs) | An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product. | From the time of informed consent signed through 90 days after last dose of AK105 |
| Observed concentrations of AK105 | The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration. | From first dose of AK105 through 90 days after last dose of AK105 |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). | From first dose of AK105 through 90 days after last dose of AK105 |
| ORR as assessed by investigator per RECIST v1.1 for anti-tumor activity in the FAS population | ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. | up to 2 years |
| Time to response (TTR) assessed by IRRC and investigator ; | TTR is defined as the time from the first dose of study drug to the first documented response (CR or PR). | up to 2 years |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| 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 |