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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04985825
Recruitment Status : Suspended (Business decision)
First Posted : August 2, 2021
Last Update Posted : May 23, 2022
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Centessa Pharmaceuticals plc ( Pega-One S.A.S. )

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.

Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma Drug: Imgatuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)
Actual Study Start Date : December 16, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. Incidence of Adverse Events [ Time Frame: Up to 24 months ]
    Safety and tolerability profile assessed by Common Terminology Criteria for Adverse Events v5.0

  21. Frequency of dose interruptions and reductions [ Time Frame: Up to 24 months ]
    Safety and tolerability profile assessed by frequency of dose interruptions and reductions

  22. Duration of dose interruptions and reductions [ Time Frame: Up to 24 months ]
    Safety and tolerability profile assessed by duration of dose interruptions and reductions

  23. Concentrations of imgatuzumab-reactive antibodies [ Time Frame: Up to 24 months ]
    Immunogenicity profile characterized by concentrations of imgatuzumab-reactive antibodies

  24. Maximum observed concentration (C[max]) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of imgatuzumab

  25. Area under the curve (AUC) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the area under the curve (AUC) of imgatuzumab

  26. 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

  27. Time to maximum concentration (Tmax) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of imgatuzumab

  28. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04985825


Locations
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Australia, New South Wales
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Pega-One S.A.S.
ICON plc
Investigators
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Study Director: Steffen Heeger, MD, PhD PegaOne S.A.S.
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Responsible Party: Pega-One S.A.S.
ClinicalTrials.gov Identifier: NCT04985825    
Other Study ID Numbers: PO-001
2021-003262-12 ( EudraCT Number )
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centessa Pharmaceuticals plc ( Pega-One S.A.S. ):
Cutaneous Squamous Cell Carcinoma
Epidermal Growth Factor Receptor
Antibody-dependent Cellular Cytotoxicity
Carcinoma
Cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell