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Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
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The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib/II | Experimental | Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI318 | Drug | IBI318 will be given fixed dose via intravenous (IV) infusion on Day 1 of each 14-day cycle until disease progression or loss of clinical benefit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome | RECIST version 1.1 will be used to determine ORR by IRRC | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessments of Overall Response Rate | RECIST version 1.1 will be used to determine ORR by investigator | 24 months |
| Duration of response | RECIST version 1.1 will be used to determine DOR by investigator and IRRC |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | China |
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| 24 months |
| PFS (progression-free survival) | RECIST version 1.1 will be used to determine PFS by investigator and IRRC | 24 months |
| Overall Survival | 24 months |
| AEs and SAEs | To evaluate the safety and tolerability of IBI318 [Adverse events (AEs), Serious Adverse Events (SAEs) ] | 30 months |