NCT04611321TerminatedPhase 1
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.
Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country15 target enrollmentStarted: December 1, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Phase Ib/II
Experimental
Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.
Intervention: IBI318 (Drug)
Outcomes
Primary Outcomes
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
Time Frame: 24 months
RECIST version 1.1 will be used to determine ORR by IRRC
Secondary Outcomes
- Investigator Assessments of Overall Response Rate(24 months)
- Duration of response(24 months)
- PFS (progression-free survival)(24 months)
- Overall Survival(24 months)
- AEs and SAEs(30 months)
Investigators
Study Sites (1)
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