Clinical trial · Interventional
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)
NCT00093041CI-TRIAL-00067617completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zalutumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Zalutumumab 0.15 mg/kg
- interventionNames
- Drug: Zalutumumab
- type
- EXPERIMENTAL
- label
- Zalutumumab 0.5 mg/kg
- interventionNames
- Drug: Zalutumumab
- type
- EXPERIMENTAL
- label
- Zalutumumab 1 mg/kg
- interventionNames
- Drug: Zalutumumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTBastholt 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. PMID 17602769