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Clinical Trials/NCT04611321
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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