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

September 12, 2022 updated by: Pega-One S.A.S.

Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Imgatuzumab monotherapy
Drug: Imgatuzumab
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria
Time Frame: Up to 24 months
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) assessed by the ICRC according to the Study Response Criteria
Up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR) assessed by the ICRC according to the Study Response Criteria
Time Frame: Up to 24 months
Proportion of patients achieving CR, PR or Stable Disease (SD) assessed by the ICRC according to the Study Response Criteria
Up to 24 months
ORR assessed by the investigator according to the Study Response Criteria
Time Frame: Up to 24 months
Proportion of patients achieving CR or PR assessed by the investigator according to the Study Response Criteria
Up to 24 months
DCR assessed by the investigator according to the Study Response Criteria
Time Frame: Up to 24 months
Proportion of patients achieving CR, PR or SD assessed by the investigator according to the Study Response Criteria
Up to 24 months
Progression-free Survival (PFS) assessed by the ICRC
Time Frame: Up to 24 months
Time from date of start of treatment to date of the first progression documented by the ICRC
Up to 24 months
Duration of Response (DoR) assessed by the ICRC
Time Frame: Up to 24 months
Time from date of first assessment of response (CR or PR) to date of the first progression documented by the ICRC
Up to 24 months
Duration of Stable Disease (DoSD) assessed by the ICRC
Time Frame: Up to 24 months
Time from date of first assessment of SD to date of the first progression documented by the ICRC
Up to 24 months
PFS assessed by the investigator
Time Frame: Up to 24 months
Time from date of start of treatment to date of the first progression documented by the investigator
Up to 24 months
DoR assessed by the investigator
Time Frame: Up to 24 months
Time from date of first assessment of response (CR or PR) to date of the first progression documented by the investigator
Up to 24 months
DoSD assessed by the investigator
Time Frame: Up to 24 months
Time from date of first assessment of SD to date of the first progression documented by the investigator
Up to 24 months
ORR assessed by the ICRC according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Time Frame: Up to 24 months
Proportion of patients achieving CR or PR assessed by the ICRC according to the iRECIST
Up to 24 months
ORR assessed by the investigator according to the iRECIST
Time Frame: Up to 24 months
Proportion of patients achieving CR or PR assessed by the investigator according to the iRECIST
Up to 24 months
DCR assessed by the ICRC according to the iRECIST
Time Frame: Up to 24 months
Proportion of patients achieving CR, PR or SD assessed by the ICRC according to the iRECIST
Up to 24 months
DCR assessed by the investigator according to the iRECIST
Time Frame: Up to 24 months
Proportion of patients achieving CR, PR or SD assessed by the investigator according to the iRECIST
Up to 24 months
PFS assessed by the ICRC according to the iRECIST
Time Frame: Up to 24 months
Time from date of start of treatment to date of the first iRECIST progression documented by the ICRC
Up to 24 months
PFS assessed by the investigator according to the iRECIST
Time Frame: Up to 24 months
Time from date of start of treatment to date of the first iRECIST progression documented by the investigator
Up to 24 months
DoR assessed by the ICRC according to the iRECIST
Time Frame: Up to 24 months
Time from date of first assessment of response (CR or PR) to date of the first iRECIST progression documented by the ICRC
Up to 24 months
DoR assessed by the investigator according to the iRECIST
Time Frame: Up to 24 months
Time from date of first assessment of response (CR or PR) to date of the first iRECIST progression documented by the investigator
Up to 24 months
DoSD assessed by the ICRC according to the iRECIST
Time Frame: Up to 24 months
Time from date of first assessment of SD to date of the first iRECIST progression documented by the ICRC
Up to 24 months
DoSD assessed by the investigator according to the iRECIST
Time Frame: Up to 24 months
Time from date of first assessment of SD to date of the first iRECIST progression documented by the investigator
Up to 24 months
Incidence of Adverse Events
Time Frame: Up to 24 months
Safety and tolerability profile assessed by Common Terminology Criteria for Adverse Events v5.0
Up to 24 months
Frequency of dose interruptions and reductions
Time Frame: Up to 24 months
Safety and tolerability profile assessed by frequency of dose interruptions and reductions
Up to 24 months
Duration of dose interruptions and reductions
Time Frame: Up to 24 months
Safety and tolerability profile assessed by duration of dose interruptions and reductions
Up to 24 months
Concentrations of imgatuzumab-reactive antibodies
Time Frame: Up to 24 months
Immunogenicity profile characterized by concentrations of imgatuzumab-reactive antibodies
Up to 24 months
Maximum observed concentration (C[max])
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of imgatuzumab
Up to 24 months
Area under the curve (AUC)
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the area under the curve (AUC) of imgatuzumab
Up to 24 months
Terminal half-life (t[1/2])
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of imgatuzumab
Up to 24 months
Time to maximum concentration (Tmax)
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of imgatuzumab
Up to 24 months
Change in scores of patient-reported outcomes
Time Frame: Up to 24 months
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
Up to 24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pega-One S.A.S.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ICON plc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Steffen Heeger, MD, PhD, PegaOne S.A.S.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PO-001
  • 2021-003262-12 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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