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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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]

2021-003262-12

Secondary ID [2]

PO-001

Universal Trial Number (UTN)

Trial acronym

I-PACE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cutaneous Squamous Cell Carcinoma

Condition category

Condition code

Cancer

Non melanoma skin cancer

Cancer

Kidney

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Imgatuzumab

Experimental: Imgatuzumab monotherapy -

Treatment: Drugs: 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.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria

Timepoint [1]

Up to 24 months

Secondary outcome [1]

Disease Control Rate (DCR) assessed by the ICRC according to the Study Response Criteria

Timepoint [1]

Up to 24 months

Secondary outcome [2]

ORR assessed by the investigator according to the Study Response Criteria

Timepoint [2]

Up to 24 months

Secondary outcome [3]

DCR assessed by the investigator according to the Study Response Criteria

Timepoint [3]

Up to 24 months

Secondary outcome [4]

Progression-free Survival (PFS) assessed by the ICRC

Timepoint [4]

Up to 24 months

Secondary outcome [5]

Duration of Response (DoR) assessed by the ICRC

Timepoint [5]

Up to 24 months

Secondary outcome [6]

Duration of Stable Disease (DoSD) assessed by the ICRC

Timepoint [6]

Up to 24 months

Secondary outcome [7]

PFS assessed by the investigator

Timepoint [7]

Up to 24 months

Secondary outcome [8]

DoR assessed by the investigator

Timepoint [8]

Up to 24 months

Secondary outcome [9]

DoSD assessed by the investigator

Timepoint [9]

Up to 24 months

Secondary outcome [10]

ORR assessed by the ICRC according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST)

Timepoint [10]

Up to 24 months

Secondary outcome [11]

ORR assessed by the investigator according to the iRECIST

Timepoint [11]

Up to 24 months

Secondary outcome [12]

DCR assessed by the ICRC according to the iRECIST

Timepoint [12]

Up to 24 months

Secondary outcome [13]

DCR assessed by the investigator according to the iRECIST

Timepoint [13]

Up to 24 months

Secondary outcome [14]

PFS assessed by the ICRC according to the iRECIST

Timepoint [14]

Up to 24 months

Secondary outcome [15]

PFS assessed by the investigator according to the iRECIST

Timepoint [15]

Up to 24 months

Secondary outcome [16]

DoR assessed by the ICRC according to the iRECIST

Timepoint [16]

Up to 24 months

Secondary outcome [17]

DoR assessed by the investigator according to the iRECIST

Timepoint [17]

Up to 24 months

Secondary outcome [18]

DoSD assessed by the ICRC according to the iRECIST

Timepoint [18]

Up to 24 months

Secondary outcome [19]

DoSD assessed by the investigator according to the iRECIST

Timepoint [19]

Up to 24 months

Secondary outcome [20]

Incidence of Adverse Events

Timepoint [20]

Up to 24 months

Secondary outcome [21]

Frequency of dose interruptions and reductions

Timepoint [21]

Up to 24 months

Secondary outcome [22]

Duration of dose interruptions and reductions

Timepoint [22]

Up to 24 months

Secondary outcome [23]

Concentrations of imgatuzumab-reactive antibodies

Timepoint [23]

Up to 24 months

Secondary outcome [24]

Maximum observed concentration (C[max])

Timepoint [24]

Up to 24 months

Secondary outcome [25]

Area under the curve (AUC)

Timepoint [25]

Up to 24 months

Secondary outcome [26]

Terminal half-life (t[1/2])

Timepoint [26]

Up to 24 months

Secondary outcome [27]

Time to maximum concentration (Tmax)

Timepoint [27]

Up to 24 months

Secondary outcome [28]

Change in scores of patient-reported outcomes

Timepoint [28]

Up to 24 months

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?

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

N/A

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

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Primary sponsor type

Commercial sector/Industry

Name

Pega-One S.A.S.

Address

Country

Other collaborator category [1]

Commercial sector/Industry

Name [1]

ICON plc

Address [1]

Country [1]

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/ct2/show/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

Steffen Heeger, MD, PhD

Address

PegaOne S.A.S.

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04985825

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04985825