Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Innovent Biologics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Cutaneous Squamous Cell Carcinoma

Treatments: Drug: IBI318

Study type: Interventional

Funder types: Industry

Identifiers

NCT04611321

CIBI318A201

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Phase Ib/II

Experimental group

Description:

Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.

Treatment:

Drug: IBI318