Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma

NCT04985825 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: PO-0012021-003262-12
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cutaneous Squamous Cell Carcinoma

Keywords

Cutaneous Squamous Cell Carcinoma; Epidermal Growth Factor Receptor; Antibody-dependent Cellular Cytotoxicity; Carcinoma; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 24 months

Secondary Outcomes (28)

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

  Up to 24 months

• ORR assessed by the investigator according to the Study Response Criteria

  Up to 24 months

• DCR assessed by the investigator according to the Study Response Criteria

  Up to 24 months

• Progression-free Survival (PFS) assessed by the ICRC

  Up to 24 months

• Duration of Response (DoR) assessed by the ICRC

  Up to 24 months

Study Arms (1)

Imgatuzumab monotherapy

EXPERIMENTAL

Drug: Imgatuzumab

Interventions

Imgatuzumab DRUG

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.

Imgatuzumab monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pega-One S.A.S.: lead
• ICON plc: collaborator

MeSH Terms

Conditions

Carcinoma; Neoplasms

Interventions

imgatuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Steffen Heeger, MD, PhD

  PegaOne S.A.S.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 2, 2021
• Study Start: December 16, 2021
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share