Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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.

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04611321

Enrollment

Registered

2020-11-02

Start date

2020-12-01

Completion date

2023-03-10

Last updated

2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cutaneous Squamous Cell Carcinoma

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.

Interventions

DRUGIBI318

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 \[Adverse events (AEs), Serious Adverse Events (SAEs) \]

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026