Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ib/II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of IBI318 in Participants With Advanced Cutaneous Squamous Cell Carcinoma.

Conditions
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Advanced Cutaneous Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: IBI318


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and willing to sign the ICF. Adults 18 years of age or older. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy at least 12 weeks. Adequate organ and bone marrow function. Histologically confirmed diagnosis of invasive CSCC. . Exclusion Criteria: Prior treatment with an agent that blocks the PD-1/PD-L1 pathway. Any investigational drugs received within 4 weeks prior to the first study treatment. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy. History of autoimmune disease , present active autoimmune disease or inflammatory diseases Pregnant or nursing females.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase Ib/II<br>Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks. | Drug: IBI318<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |