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Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)

Primary Purpose

Cutaneous Squamous Cell Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Imgatuzumab
Sponsored by
Pega-One S.A.S.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma focused on measuring Cutaneous Squamous Cell Carcinoma, Epidermal Growth Factor Receptor, Antibody-dependent Cellular Cytotoxicity, Carcinoma, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of CSCC
  • CSCC of advanced stage
  • Males or females at least 18 years of age at the time of consent
  • Signed informed consent provided prior to any study procedures
  • Ability to and willing to understand informed consent and comply with protocol requirements and procedures
  • No more than two prior lines of systemic treatment for advanced disease
  • Patients must have at least one lesion that is considered as measurable according to the Study Response Criteria
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Adequate function of bone marrow, liver, kidneys
  • Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at Screening

Key Exclusion Criteria:

  • Prior systemic treatment for advanced disease with any anti-EGFR agent
  • Active central nervous system metastasis
  • Systemic anti-cancer therapy within five half-lives or two weeks, whichever is shorter, prior to first dose of the study drug
  • Persistent toxicities from previous systemic anti-neoplastic treatments
  • Wide-field radiotherapy within four weeks, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within two weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
  • Major surgery within four weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
  • Active infection requiring therapy
  • Concomitant use of systemic steroids at dose of >10 mg of prednisone or its equivalent per day
  • Known or suspected allergy/hypersensitivity to the study drug or any component of the study drug, other monoclonal antibodies, premedication medicines
  • Concurrent participation in another investigational therapeutic clinical trial
  • Pregnant or breast-feeding females
  • Mental or medical conditions that prevent the patient from giving informed consent or participating in the trial
  • Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Imgatuzumab monotherapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria
    Proportion of patients achieving Complete Response (CR) or Partial Response (PR) assessed by the ICRC according to the Study Response Criteria

    Secondary Outcome Measures

    Disease Control Rate (DCR) assessed by the ICRC according to the Study Response Criteria
    Proportion of patients achieving CR, PR or Stable Disease (SD) assessed by the ICRC according to the Study Response Criteria
    ORR assessed by the investigator according to the Study Response Criteria
    Proportion of patients achieving CR or PR assessed by the investigator according to the Study Response Criteria
    DCR assessed by the investigator according to the Study Response Criteria
    Proportion of patients achieving CR, PR or SD assessed by the investigator according to the Study Response Criteria
    Progression-free Survival (PFS) assessed by the ICRC
    Time from date of start of treatment to date of the first progression documented by the ICRC
    Duration of Response (DoR) assessed by the ICRC
    Time from date of first assessment of response (CR or PR) to date of the first progression documented by the ICRC
    Duration of Stable Disease (DoSD) assessed by the ICRC
    Time from date of first assessment of SD to date of the first progression documented by the ICRC
    PFS assessed by the investigator
    Time from date of start of treatment to date of the first progression documented by the investigator
    DoR assessed by the investigator
    Time from date of first assessment of response (CR or PR) to date of the first progression documented by the investigator
    DoSD assessed by the investigator
    Time from date of first assessment of SD to date of the first progression documented by the investigator
    ORR assessed by the ICRC according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST)
    Proportion of patients achieving CR or PR assessed by the ICRC according to the iRECIST
    ORR assessed by the investigator according to the iRECIST
    Proportion of patients achieving CR or PR assessed by the investigator according to the iRECIST
    DCR assessed by the ICRC according to the iRECIST
    Proportion of patients achieving CR, PR or SD assessed by the ICRC according to the iRECIST
    DCR assessed by the investigator according to the iRECIST
    Proportion of patients achieving CR, PR or SD assessed by the investigator according to the iRECIST
    PFS assessed by the ICRC according to the iRECIST
    Time from date of start of treatment to date of the first iRECIST progression documented by the ICRC
    PFS assessed by the investigator according to the iRECIST
    Time from date of start of treatment to date of the first iRECIST progression documented by the investigator
    DoR assessed by the ICRC according to the iRECIST
    Time from date of first assessment of response (CR or PR) to date of the first iRECIST progression documented by the ICRC
    DoR assessed by the investigator according to the iRECIST
    Time from date of first assessment of response (CR or PR) to date of the first iRECIST progression documented by the investigator
    DoSD assessed by the ICRC according to the iRECIST
    Time from date of first assessment of SD to date of the first iRECIST progression documented by the ICRC
    DoSD assessed by the investigator according to the iRECIST
    Time from date of first assessment of SD to date of the first iRECIST progression documented by the investigator
    Incidence of Adverse Events
    Safety and tolerability profile assessed by Common Terminology Criteria for Adverse Events v5.0
    Frequency of dose interruptions and reductions
    Safety and tolerability profile assessed by frequency of dose interruptions and reductions
    Duration of dose interruptions and reductions
    Safety and tolerability profile assessed by duration of dose interruptions and reductions
    Concentrations of imgatuzumab-reactive antibodies
    Immunogenicity profile characterized by concentrations of imgatuzumab-reactive antibodies
    Maximum observed concentration (C[max])
    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of imgatuzumab
    Area under the curve (AUC)
    Pharmacokinetic profile characterized by the area under the curve (AUC) of imgatuzumab
    Terminal half-life (t[1/2])
    Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of imgatuzumab
    Time to maximum concentration (Tmax)
    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of imgatuzumab
    Change in scores of patient-reported outcomes
    Quality of life assessed by change in scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed linearly to a zero to 100 scale. A higher score on the functional scale and the global Health related Quality of Life indicates better functioning

    Full Information

    First Posted
    July 20, 2021
    Last Updated
    September 12, 2022
    Sponsor
    Pega-One S.A.S.
    Collaborators
    ICON plc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04985825
    Brief Title
    Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma
    Acronym
    I-PACE
    Official Title
    Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision
    Study Start Date
    December 16, 2021 (Actual)
    Primary Completion Date
    August 17, 2022 (Actual)
    Study Completion Date
    August 17, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pega-One S.A.S.
    Collaborators
    ICON plc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the anti-tumor activity, safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of imgatuzumab, a monoclonal antibody against epidermal growth factor receptor (EGFR) with enhanced antibody-dependent cellular cytotoxicity (ADCC) in patients with advanced cutaneous squamous cell carcinoma (CSCC). Quality of life of patients treated with imgatuzumab will also be assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cutaneous Squamous Cell Carcinoma
    Keywords
    Cutaneous Squamous Cell Carcinoma, Epidermal Growth Factor Receptor, Antibody-dependent Cellular Cytotoxicity, Carcinoma, Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Imgatuzumab monotherapy
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Imgatuzumab
    Intervention Description
    Imgatuzumab administered as an intravenous infusion on Day 1 and Day 8 of the first 21-day cycle, and on Day 1 of each subsequent 14-day cycle.
    Primary Outcome Measure Information:
    Title
    Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria
    Description
    Proportion of patients achieving Complete Response (CR) or Partial Response (PR) assessed by the ICRC according to the Study Response Criteria
    Time Frame
    Up to 24 months
    Secondary Outcome Measure Information:
    Title
    Disease Control Rate (DCR) assessed by the ICRC according to the Study Response Criteria
    Description
    Proportion of patients achieving CR, PR or Stable Disease (SD) assessed by the ICRC according to the Study Response Criteria
    Time Frame
    Up to 24 months
    Title
    ORR assessed by the investigator according to the Study Response Criteria
    Description
    Proportion of patients achieving CR or PR assessed by the investigator according to the Study Response Criteria
    Time Frame
    Up to 24 months
    Title
    DCR assessed by the investigator according to the Study Response Criteria
    Description
    Proportion of patients achieving CR, PR or SD assessed by the investigator according to the Study Response Criteria
    Time Frame
    Up to 24 months
    Title
    Progression-free Survival (PFS) assessed by the ICRC
    Description
    Time from date of start of treatment to date of the first progression documented by the ICRC
    Time Frame
    Up to 24 months
    Title
    Duration of Response (DoR) assessed by the ICRC
    Description
    Time from date of first assessment of response (CR or PR) to date of the first progression documented by the ICRC
    Time Frame
    Up to 24 months
    Title
    Duration of Stable Disease (DoSD) assessed by the ICRC
    Description
    Time from date of first assessment of SD to date of the first progression documented by the ICRC
    Time Frame
    Up to 24 months
    Title
    PFS assessed by the investigator
    Description
    Time from date of start of treatment to date of the first progression documented by the investigator
    Time Frame
    Up to 24 months
    Title
    DoR assessed by the investigator
    Description
    Time from date of first assessment of response (CR or PR) to date of the first progression documented by the investigator
    Time Frame
    Up to 24 months
    Title
    DoSD assessed by the investigator
    Description
    Time from date of first assessment of SD to date of the first progression documented by the investigator
    Time Frame
    Up to 24 months
    Title
    ORR assessed by the ICRC according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST)
    Description
    Proportion of patients achieving CR or PR assessed by the ICRC according to the iRECIST
    Time Frame
    Up to 24 months
    Title
    ORR assessed by the investigator according to the iRECIST
    Description
    Proportion of patients achieving CR or PR assessed by the investigator according to the iRECIST
    Time Frame
    Up to 24 months
    Title
    DCR assessed by the ICRC according to the iRECIST
    Description
    Proportion of patients achieving CR, PR or SD assessed by the ICRC according to the iRECIST
    Time Frame
    Up to 24 months
    Title
    DCR assessed by the investigator according to the iRECIST
    Description
    Proportion of patients achieving CR, PR or SD assessed by the investigator according to the iRECIST
    Time Frame
    Up to 24 months
    Title
    PFS assessed by the ICRC according to the iRECIST
    Description
    Time from date of start of treatment to date of the first iRECIST progression documented by the ICRC
    Time Frame
    Up to 24 months
    Title
    PFS assessed by the investigator according to the iRECIST
    Description
    Time from date of start of treatment to date of the first iRECIST progression documented by the investigator
    Time Frame
    Up to 24 months
    Title
    DoR assessed by the ICRC according to the iRECIST
    Description
    Time from date of first assessment of response (CR or PR) to date of the first iRECIST progression documented by the ICRC
    Time Frame
    Up to 24 months
    Title
    DoR assessed by the investigator according to the iRECIST
    Description
    Time from date of first assessment of response (CR or PR) to date of the first iRECIST progression documented by the investigator
    Time Frame
    Up to 24 months
    Title
    DoSD assessed by the ICRC according to the iRECIST
    Description
    Time from date of first assessment of SD to date of the first iRECIST progression documented by the ICRC
    Time Frame
    Up to 24 months
    Title
    DoSD assessed by the investigator according to the iRECIST
    Description
    Time from date of first assessment of SD to date of the first iRECIST progression documented by the investigator
    Time Frame
    Up to 24 months
    Title
    Incidence of Adverse Events
    Description
    Safety and tolerability profile assessed by Common Terminology Criteria for Adverse Events v5.0
    Time Frame
    Up to 24 months
    Title
    Frequency of dose interruptions and reductions
    Description
    Safety and tolerability profile assessed by frequency of dose interruptions and reductions
    Time Frame
    Up to 24 months
    Title
    Duration of dose interruptions and reductions
    Description
    Safety and tolerability profile assessed by duration of dose interruptions and reductions
    Time Frame
    Up to 24 months
    Title
    Concentrations of imgatuzumab-reactive antibodies
    Description
    Immunogenicity profile characterized by concentrations of imgatuzumab-reactive antibodies
    Time Frame
    Up to 24 months
    Title
    Maximum observed concentration (C[max])
    Description
    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of imgatuzumab
    Time Frame
    Up to 24 months
    Title
    Area under the curve (AUC)
    Description
    Pharmacokinetic profile characterized by the area under the curve (AUC) of imgatuzumab
    Time Frame
    Up to 24 months
    Title
    Terminal half-life (t[1/2])
    Description
    Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of imgatuzumab
    Time Frame
    Up to 24 months
    Title
    Time to maximum concentration (Tmax)
    Description
    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of imgatuzumab
    Time Frame
    Up to 24 months
    Title
    Change in scores of patient-reported outcomes
    Description
    Quality of life assessed by change in scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed linearly to a zero to 100 scale. A higher score on the functional scale and the global Health related Quality of Life indicates better functioning
    Time Frame
    Up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Histologically confirmed diagnosis of CSCC CSCC of advanced stage Males or females at least 18 years of age at the time of consent Signed informed consent provided prior to any study procedures Ability to and willing to understand informed consent and comply with protocol requirements and procedures No more than two prior lines of systemic treatment for advanced disease Patients must have at least one lesion that is considered as measurable according to the Study Response Criteria Eastern Cooperative Oncology Group performance status 0 or 1 Adequate function of bone marrow, liver, kidneys Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at Screening Key Exclusion Criteria: Prior systemic treatment for advanced disease with any anti-EGFR agent Active central nervous system metastasis Systemic anti-cancer therapy within five half-lives or two weeks, whichever is shorter, prior to first dose of the study drug Persistent toxicities from previous systemic anti-neoplastic treatments Wide-field radiotherapy within four weeks, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within two weeks prior to first dose of the study drug, or no recovery from side effects of such intervention Major surgery within four weeks prior to first dose of the study drug, or no recovery from side effects of such intervention Active infection requiring therapy Concomitant use of systemic steroids at dose of >10 mg of prednisone or its equivalent per day Known or suspected allergy/hypersensitivity to the study drug or any component of the study drug, other monoclonal antibodies, premedication medicines Concurrent participation in another investigational therapeutic clinical trial Pregnant or breast-feeding females Mental or medical conditions that prevent the patient from giving informed consent or participating in the trial Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study Note: Other protocol defined Inclusion/Exclusion criteria apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steffen Heeger, MD, PhD
    Organizational Affiliation
    PegaOne S.A.S.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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