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

Pega-One

Status and phase

Withdrawn

Phase 2

Conditions

Cutaneous Squamous Cell Carcinoma

Treatments

Drug: Imgatuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04985825

2021-003262-12 (EudraCT Number)

PO-001

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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