Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Advanced Cutaneous Squamous Cell Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04611321
• Other study ID #: CIBI318A201
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 1, 2020
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to understand and willing to sign the ICF.

2. Adults 18 years of age or older.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Life expectancy at least 12 weeks.

5. Adequate organ and bone marrow function.

6. Histologically confirmed diagnosis of invasive CSCC. .

Exclusion Criteria:

1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.

2. Any investigational drugs received within 4 weeks prior to the first study treatment.

3. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.

4. History of autoimmune disease , present active autoimmune disease or inflammatory diseases

5. Pregnant or nursing females.

Related Conditions & MeSH terms

• Advanced Cutaneous Squamous Cell Carcinoma
• Carcinoma
• Carcinoma, Squamous Cell

Intervention

Drug:
• IBI318
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Investigator Assessments of Overall Response Rate	RECIST version 1.1 will be used to determine ORR by investigator	24 months
Secondary	Duration of response	RECIST version 1.1 will be used to determine DOR by investigator and IRRC	24 months
Secondary	PFS (progression-free survival)	RECIST version 1.1 will be used to determine PFS by investigator and IRRC	24 months
Secondary	Overall Survival		24 months
Secondary	AEs and SAEs	To evaluate the safety and tolerability of IBI318 [Adverse events (AEs), Serious Adverse Events (SAEs) ]	30 months