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Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma

NCT04985825 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-09-13

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Pega-One S.A.S.

    lead INDUSTRY

Principal Investigators

  • Steffen Heeger, MD, PhD · PegaOne S.A.S.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2022-08-17
Completion
2022-08-17
FDA Drug
Yes

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985825 on ClinicalTrials.gov