Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2022-08-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.