Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Phase 1

Terminated

• Conditions: Advanced Cutaneous Squamous Cell Carcinoma
• Interventions: Drug: IBI318

• Registration Number: NCT04611321
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Study Start: 2020-12-01
• Status Verified: 2023-03
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase Ib/II	IBI318	Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome	24 months	RECIST version 1.1 will be used to determine ORR by IRRC

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China