Zalutumumab in Head and Neck Cancer

An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Drug: Zalutumumab

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen Ø, Denmark, 2100
    • Rigshospitalet
  • Odense, Denmark, 5000
    • Odense Universitetshospital
  • Århus C, Denmark, 8000
    • Århus Kommunehospital
• Sweden
  • Lund, Sweden, 221 85
    • Universitets Sjukhuset i Lund
  • Uppsala, Sweden, 751 85
    • Uppsala Akademiska Sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx.
• Primary or recurrent disease for which no curative or established palliative treatments are amenable
• WHO performance status of 1 or 2.

Exclusion Criteria:

• Received certain other treatments within 4 weeks prior to administration of study drug
• Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis).
• Skin disease requiring systemic or local corticosteroid therapy.
• Known brain metastasis or leptomeningeal disease.
• Signs or symptoms of acute illness.
• Bacterial, fungal or viral infection.
• Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases.
• Pregnant or breast-feeding women.
• Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
• Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zalutumumab 0.15 mg/kg	Drug: Zalutumumab; Weekly infusion; Other Names: HuMax-EGFr
Experimental: Zalutumumab 0.5 mg/kg	Drug: Zalutumumab; Weekly infusion; Other Names: HuMax-EGFr
Experimental: Zalutumumab 1 mg/kg	Drug: Zalutumumab; Weekly infusion; Other Names: HuMax-EGFr
Experimental: Zalutumumab 2 mg/kg	Drug: Zalutumumab; Weekly infusion; Other Names: HuMax-EGFr
Experimental: Zalutumumab 4 mg/kg	Drug: Zalutumumab; Weekly infusion; Other Names: HuMax-EGFr
Experimental: Zalutumumab 8 mg/kg	Drug: Zalutumumab; Weekly infusion; Other Names: HuMax-EGFr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of participants reporting at least one adverse event.	From study start (Day 0) until follow-up period (up to Day 77)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response (OR), Classification	Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.	8 weeks

Collaborators and Investigators

• Sponsor: Genmab

Publications and helpful links

General Publications

• Bastholt L, Specht L, Jensen K, Brun E, Loft A, Petersen J, Kastberg H, Eriksen JG. Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck. Radiother Oncol. 2007 Oct;85(1):24-8. doi: 10.1016/j.radonc.2007.06.007. Epub 2007 Jun 28.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2003
• Primary Completion (Actual): January 12, 2005
• Study Completion (Actual): January 12, 2005

Study Registration Dates

• First Submitted: September 30, 2004
• First Submitted That Met QC Criteria: September 30, 2004
• First Posted (Estimated): October 1, 2004

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Head and neck cancer; squamous cell carcinoma of the head and neck
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Agents; Antineoplastic Agents, Immunological; Zalutumumab
• Other Study ID Numbers: Hx-EGFr-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No