Clinical trial NCT04985825: Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Official title: Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cutaneous Squamous Cell Carcinoma
Keywords: Cutaneous Squamous Cell Carcinoma
Epidermal Growth Factor Receptor
Antibody-dependent Cellular Cytotoxicity
Carcinoma
Cancer
Lead sponsor: Centessa Pharmaceuticals plc
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2021-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria
timeFrame: Up to 24 months
Secondary outcomes:
measure: Disease Control Rate (DCR) assessed by the ICRC according to the Study Response Criteria
timeFrame: Up to 24 months
measure: ORR assessed by the investigator according to the Study Response Criteria
timeFrame: Up to 24 months
measure: DCR assessed by the investigator according to the Study Response Criteria
timeFrame: Up to 24 months
measure: Progression-free Survival (PFS) assessed by the ICRC
timeFrame: Up to 24 months
measure: Duration of Response (DoR) assessed by the ICRC
timeFrame: Up to 24 months
measure: Duration of Stable Disease (DoSD) assessed by the ICRC
timeFrame: Up to 24 months
measure: PFS assessed by the investigator
timeFrame: Up to 24 months
measure: DoR assessed by the investigator
timeFrame: Up to 24 months
measure: DoSD assessed by the investigator
timeFrame: Up to 24 months
measure: ORR assessed by the ICRC according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST)
timeFrame: Up to 24 months
measure: ORR assessed by the investigator according to the iRECIST
timeFrame: Up to 24 months
measure: DCR assessed by the ICRC according to the iRECIST
timeFrame: Up to 24 months
measure: DCR assessed by the investigator according to the iRECIST
timeFrame: Up to 24 months
measure: PFS assessed by the ICRC according to the iRECIST
timeFrame: Up to 24 months
measure: PFS assessed by the investigator according to the iRECIST
timeFrame: Up to 24 months
measure: DoR assessed by the ICRC according to the iRECIST
timeFrame: Up to 24 months
measure: DoR assessed by the investigator according to the iRECIST
timeFrame: Up to 24 months
measure: DoSD assessed by the ICRC according to the iRECIST
timeFrame: Up to 24 months
measure: DoSD assessed by the investigator according to the iRECIST
timeFrame: Up to 24 months
measure: Incidence of Adverse Events
timeFrame: Up to 24 months
measure: Frequency of dose interruptions and reductions
timeFrame: Up to 24 months
measure: Duration of dose interruptions and reductions
timeFrame: Up to 24 months
measure: Concentrations of imgatuzumab-reactive antibodies
timeFrame: Up to 24 months
measure: Maximum observed concentration (C[max])
timeFrame: Up to 24 months
measure: Area under the curve (AUC)
timeFrame: Up to 24 months
measure: Terminal half-life (t[1/2])
timeFrame: Up to 24 months
measure: Time to maximum concentration (Tmax)
timeFrame: Up to 24 months
measure: Change in scores of patient-reported outcomes
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: PegaOne S.A.S.
name: Steffen Heeger, MD, PhD
role: STUDY_DIRECTOR
References: