Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Aug 28, 2022
  • participants needed
    56
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 27 January 2021

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.

Details
Condition Advanced Cutaneous Squamous Cell Carcinoma
Treatment IBI318
Clinical Study IdentifierNCT04611321
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Advanced Cutaneous Squamous Cell Carcinoma??
Able to understand and willing to sign the ICF
Adults 18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy at least 12 weeks
Adequate organ and bone marrow function
Histologically confirmed diagnosis of invasive CSCC

Exclusion Criteria

Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
Any investigational drugs received within 4 weeks prior to the first study treatment
Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy
History of autoimmune disease , present active autoimmune disease or inflammatory diseases
Pregnant or nursing females
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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