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TerminatedNCT04611321Updated Mar 28, 2023

Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

A Phase 1/2 interventional study of IBI318 in Advanced Cutaneous Squamous Cell Carcinoma, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
Phase
Phase 1/2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Advanced Cutaneous Squamous Cell Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 15 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Phase Ib/II

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

    Drug: IBI318

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.

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What researchers measure

Primary outcomes

  1. Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome

    RECIST version 1.1 will be used to determine ORR by IRRC

    Time frame: 24 months

Secondary outcomes

  1. Investigator Assessments of Overall Response Rate

    RECIST version 1.1 will be used to determine ORR by investigator

    Time frame: 24 months

  2. Duration of response

    RECIST version 1.1 will be used to determine DOR by investigator and IRRC

    Time frame: 24 months

  3. PFS (progression-free survival)

    RECIST version 1.1 will be used to determine PFS by investigator and IRRC

    Time frame: 24 months

  4. Overall Survival

    Time frame: 24 months

  5. AEs and SAEs

    To evaluate the safety and tolerability of IBI318 \[Adverse events (AEs), Serious Adverse Events (SAEs) \]

    Time frame: 30 months

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Study locations

1 site
  • Sun Yat-sen University Cancer Center
    Guangzhou, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04611321
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Nov 2, 2020
Start date
Dec 1, 2020
Primary completion
Mar 10, 2023
Completion
Mar 10, 2023
Last update
Mar 28, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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