Back to resultsStudy of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Primary Purpose
Advanced Cutaneous Squamous Cell Carcinoma
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI318
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Cutaneous Squamous Cell Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phase Ib/II
Arm Description
Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Investigator Assessments of Overall Response Rate
RECIST version 1.1 will be used to determine ORR by investigator
Duration of response
RECIST version 1.1 will be used to determine DOR by investigator and IRRC
PFS (progression-free survival)
RECIST version 1.1 will be used to determine PFS by investigator and IRRC
Overall Survival
AEs and SAEs
To evaluate the safety and tolerability of IBI318 [Adverse events (AEs), Serious Adverse Events (SAEs) ]
Full Information
NCT ID
NCT04611321
First Posted
October 27, 2020
Last Updated
March 24, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04611321
Brief Title
Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cutaneous Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase Ib/II
Arm Type
Experimental
Arm Description
Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
IBI318
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
Description
RECIST version 1.1 will be used to determine ORR by IRRC
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Investigator Assessments of Overall Response Rate
Description
RECIST version 1.1 will be used to determine ORR by investigator
Time Frame
24 months
Title
Duration of response
Description
RECIST version 1.1 will be used to determine DOR by investigator and IRRC
Time Frame
24 months
Title
PFS (progression-free survival)
Description
RECIST version 1.1 will be used to determine PFS by investigator and IRRC
Time Frame
24 months
Title
Overall Survival
Time Frame
24 months
Title
AEs and SAEs
Description
To evaluate the safety and tolerability of IBI318 [Adverse events (AEs), Serious Adverse Events (SAEs) ]
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
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