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

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• Status: Withdrawn
• Conditions: Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Imgatuzumab

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 24 months
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	Up to 24 months
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	Up to 24 months
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	Up to 24 months
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	Up to 24 months
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	Up to 24 months
PFS assessed by the investigator	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 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 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)	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	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	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	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 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 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 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 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 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 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	Safety and tolerability profile assessed by Common Terminology Criteria for Adverse Events v5.0	Up to 24 months
Frequency of dose interruptions and reductions	Safety and tolerability profile assessed by frequency of dose interruptions and reductions	Up to 24 months
Duration of dose interruptions and reductions	Safety and tolerability profile assessed by duration of dose interruptions and reductions	Up to 24 months
Concentrations of imgatuzumab-reactive antibodies	Immunogenicity profile characterized by concentrations of imgatuzumab-reactive antibodies	Up to 24 months
Maximum observed concentration (C[max])	Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of imgatuzumab	Up to 24 months
Area under the curve (AUC)	Pharmacokinetic profile characterized by the area under the curve (AUC) of imgatuzumab	Up to 24 months
Terminal half-life (t[1/2])	Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of imgatuzumab	Up to 24 months
Time to maximum concentration (Tmax)	Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of imgatuzumab	Up to 24 months
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	Up to 24 months

Collaborators and Investigators

• Sponsor: Pega-One S.A.S.
• Collaborators: ICON plc
• Investigators: Study Director: Steffen Heeger, MD, PhD, PegaOne S.A.S.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2021
• Primary Completion (ACTUAL): August 17, 2022
• Study Completion (ACTUAL): August 17, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (ACTUAL): August 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Carcinoma; Cutaneous Squamous Cell Carcinoma; Epidermal Growth Factor Receptor; Antibody-dependent Cellular Cytotoxicity
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID 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