Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

NCT ID: NCT04611321

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-03-10

Brief Summary

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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

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Conditions

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Advanced Cutaneous Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase Ib/II

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

Group Type EXPERIMENTAL

IBI318

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status

Countries

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China

Other Identifiers

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CIBI318A201

Identifier Type: -

Identifier Source: org_study_id

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