Cutaneous Squamous Cell CarcinomaPhase 2I-PACENCT04985825
Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma
A Phase 2 study testing Imgatuzumab in people with Cutaneous Squamous Cell Carcinoma, run by Pega-One S.A.S..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Imgatuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2021to 17 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
About this study
Official title: Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)
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.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Imgatuzumab
- Keywords
- Cutaneous Squamous Cell Carcinoma, Epidermal Growth Factor Receptor, Antibody-dependent Cellular Cytotoxicity, Carcinoma, Cancer
- Medical subject headings
- Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImgatuzumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Imgatuzumab monotherapy | Experimental | Not described Receives: Drug: Imgatuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) assessed by the ICRC according to the Study Response Criteria
Measured: Up to 24 months
Secondary outcomes (28)
Disease Control Rate (DCR) assessed by the ICRC according to the Study Response Criteria
Proportion of patients achieving CR, PR or Stable Disease (SD) assessed by the ICRC according to the Study Response Criteria
Measured: Up to 24 months
ORR assessed by the investigator according to the Study Response Criteria
Proportion of patients achieving CR or PR assessed by the investigator according to the Study Response Criteria
Measured: Up to 24 months
DCR assessed by the investigator according to the Study Response Criteria
Proportion of patients achieving CR, PR or SD assessed by the investigator according to the Study Response Criteria
Measured: Up to 24 months
Progression-free Survival (PFS) assessed by the ICRC
Time from date of start of treatment to date of the first progression documented by the ICRC
Measured: Up to 24 months
Duration of Response (DoR) assessed by the ICRC
Time from date of first assessment of response (CR or PR) to date of the first progression documented by the ICRC
Measured: Up to 24 months
Duration of Stable Disease (DoSD) assessed by the ICRC
Time from date of first assessment of SD to date of the first progression documented by the ICRC
Measured: Up to 24 months
PFS assessed by the investigator
Time from date of start of treatment to date of the first progression documented by the investigator
Measured: Up to 24 months
DoR assessed by the investigator
Time from date of first assessment of response (CR or PR) to date of the first progression documented by the investigator
Measured: Up to 24 months
DoSD assessed by the investigator
Time from date of first assessment of SD to date of the first progression documented by the investigator
Measured: Up to 24 months
ORR assessed by the ICRC according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Proportion of patients achieving CR or PR assessed by the ICRC according to the iRECIST
Measured: Up to 24 months
ORR assessed by the investigator according to the iRECIST
Proportion of patients achieving CR or PR assessed by the investigator according to the iRECIST
Measured: Up to 24 months
DCR assessed by the ICRC according to the iRECIST
Proportion of patients achieving CR, PR or SD assessed by the ICRC according to the iRECIST
Measured: Up to 24 months
DCR assessed by the investigator according to the iRECIST
Proportion of patients achieving CR, PR or SD assessed by the investigator according to the iRECIST
Measured: Up to 24 months
PFS assessed by the ICRC according to the iRECIST
Time from date of start of treatment to date of the first iRECIST progression documented by the ICRC
Measured: Up to 24 months
PFS assessed by the investigator according to the iRECIST
Time from date of start of treatment to date of the first iRECIST progression documented by the investigator
Measured: Up to 24 months
DoR assessed by the ICRC according to the iRECIST
Time from date of first assessment of response (CR or PR) to date of the first iRECIST progression documented by the ICRC
Measured: Up to 24 months
DoR assessed by the investigator according to the iRECIST
Time from date of first assessment of response (CR or PR) to date of the first iRECIST progression documented by the investigator
Measured: Up to 24 months
DoSD assessed by the ICRC according to the iRECIST
Time from date of first assessment of SD to date of the first iRECIST progression documented by the ICRC
Measured: Up to 24 months
DoSD assessed by the investigator according to the iRECIST
Time from date of first assessment of SD to date of the first iRECIST progression documented by the investigator
Measured: Up to 24 months
Incidence of Adverse Events
Safety and tolerability profile assessed by Common Terminology Criteria for Adverse Events v5.0
Measured: Up to 24 months
Frequency of dose interruptions and reductions
Safety and tolerability profile assessed by frequency of dose interruptions and reductions
Measured: Up to 24 months
Duration of dose interruptions and reductions
Safety and tolerability profile assessed by duration of dose interruptions and reductions
Measured: Up to 24 months
Concentrations of imgatuzumab-reactive antibodies
Immunogenicity profile characterized by concentrations of imgatuzumab-reactive antibodies
Measured: Up to 24 months
Maximum observed concentration (C[max])
Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of imgatuzumab
Measured: Up to 24 months
Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of imgatuzumab
Measured: Up to 24 months
Terminal half-life (t[1/2])
Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of imgatuzumab
Measured: Up to 24 months
Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of imgatuzumab
Measured: Up to 24 months
Change in scores of patient-reported outcomes
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
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start16 Dec 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pega-One S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Steffen Heeger, MD, PhD, Study director, PegaOne S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985825
- Sponsor's protocol ID
- PO-001
- Other IDs
- 2021-003262-12
- Acronym
- I-PACE
- Status last verified
- Sep 2022
- First submitted
- 20 Jul 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (I-PACE)
- ClinicalTrials.gov ID
- NCT04985825
- Acronym / sponsor ID
- I-PACE / PO-001
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Keywords
- Cutaneous Squamous Cell Carcinoma, Epidermal Growth Factor Receptor, Antibody-dependent Cellular Cytotoxicity, Carcinoma, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pega-One S.A.S.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imgatuzumab monotherapy | Experimental | Drug: Imgatuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImgatuzumabImgatuzumab 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. | Drug | Imgatuzumab monotherapy |
Primary outcome
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
28 secondary outcomes
Disease Control Rate (DCR) assessed by the ICRC according to the Study Response Criteria
Time frame: Up to 24 months
ORR assessed by the investigator according to the Study Response Criteria
Time frame: Up to 24 months
DCR assessed by the investigator according to the Study Response Criteria
Time frame: Up to 24 months
Progression-free Survival (PFS) assessed by the ICRC
Time frame: Up to 24 months
Duration of Response (DoR) assessed by the ICRC
Time frame: Up to 24 months
Duration of Stable Disease (DoSD) assessed by the ICRC
Time frame: Up to 24 months
PFS assessed by the investigator
Time frame: Up to 24 months
DoR assessed by the investigator
Time frame: Up to 24 months
DoSD assessed by the investigator
Time frame: Up to 24 months
ORR assessed by the ICRC according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: Up to 24 months
ORR assessed by the investigator according to the iRECIST
Time frame: Up to 24 months
DCR assessed by the ICRC according to the iRECIST
Time frame: Up to 24 months
DCR assessed by the investigator according to the iRECIST
Time frame: Up to 24 months
PFS assessed by the ICRC according to the iRECIST
Time frame: Up to 24 months
PFS assessed by the investigator according to the iRECIST
Time frame: Up to 24 months
DoR assessed by the ICRC according to the iRECIST
Time frame: Up to 24 months
DoR assessed by the investigator according to the iRECIST
Time frame: Up to 24 months
DoSD assessed by the ICRC according to the iRECIST
Time frame: Up to 24 months
DoSD assessed by the investigator according to the iRECIST
Time frame: Up to 24 months
Incidence of Adverse Events
Time frame: Up to 24 months
Frequency of dose interruptions and reductions
Time frame: Up to 24 months
Duration of dose interruptions and reductions
Time frame: Up to 24 months
Concentrations of imgatuzumab-reactive antibodies
Time frame: Up to 24 months
Maximum observed concentration (C[max])
Time frame: Up to 24 months
Area under the curve (AUC)
Time frame: Up to 24 months
Terminal half-life (t[1/2])
Time frame: Up to 24 months
Time to maximum concentration (Tmax)
Time frame: Up to 24 months
Change in scores of patient-reported outcomes
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Heeger, MD, PhD study director
PegaOne S.A.S.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imgatuzumab in people with Cutaneous Squamous Cell Carcinoma, run by Pega-One S.A.S..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) assessed by the Independent Central Review Committee (ICRC) according to the Study Response Criteria (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.