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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04985825




Registration number
NCT04985825
Ethics application status
Date submitted
20/07/2021
Date registered
2/08/2021
Date last updated
13/09/2022

Titles & IDs
Public title
Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Scientific title
Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)
Secondary ID [1] 0 0
2021-003262-12
Secondary ID [2] 0 0
PO-001
Universal Trial Number (UTN)
Trial acronym
I-PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/08/2022
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pega-One S.A.S.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04985825
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Steffen Heeger, MD, PhD
Address 0 0
PegaOne S.A.S.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04985825