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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003262-12 | EudraCT Number |
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Business decision
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imgatuzumab monotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imgatuzumab | Drug | 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. |
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| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Heeger, MD, PhD | PegaOne S.A.S. | Study Director |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C569293 | imgatuzumab |
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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 |