Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

March 24, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase Ib/II
Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
Time Frame: 24 months
RECIST version 1.1 will be used to determine ORR by IRRC
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 24 months
24 months
Investigator Assessments of Overall Response Rate
Time Frame: 24 months
RECIST version 1.1 will be used to determine ORR by investigator
24 months
Duration of response
Time Frame: 24 months
RECIST version 1.1 will be used to determine DOR by investigator and IRRC
24 months
PFS (progression-free survival)
Time Frame: 24 months
RECIST version 1.1 will be used to determine PFS by investigator and IRRC
24 months
AEs and SAEs
Time Frame: 30 months
To evaluate the safety and tolerability of IBI318 [Adverse events (AEs), Serious Adverse Events (SAEs) ]
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

March 10, 2023

Study Completion (Actual)

March 10, 2023

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI318A201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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