111In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen
Condition: Neoplasms
Intervention: ch806
Intervention description: ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open label, single dose escalation Phase I trial of ch806 in patients with advanced tumors expressing the 806 antigen.
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical trial is to describe the toxicity, biodistribution,
      pharmacokinetics and tumour uptake of a single infusion of ch806 (tagged with a trace amount
      of radioactive 111-Indium: 111In-ch806) in patients with advanced tumours expressing the 806
      antigen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with advanced or metastatic tumours which are positive for 806 antigen
             expression based on chromogenic in situ hybridization (CISH) or immuno-histochemistry
             (IHC) of archived tumour samples.

          -  Histologically or cytologically proven malignancy.

          -  Measurable disease on CT scan with at least one lesion >/= 2 cm diameter (to allow
             adequate imaging).

          -  Age greater than or equal to 18 years.

          -  Karnofsky performance scale >/= 70.

          -  Within the last 2 weeks vital laboratory parameters should be within normal range,
             except for the following laboratory parameters, which should be within the ranges
             specified: Neutrophil count >/= 1.5 x 10^9/L; Platelet count >/= 150 x 10^9/L; Serum
             bilirubin < 34 micromol/L; Creatinine clearance > 50ml/min

          -  Able and willing to give valid written informed consent.

        Exclusion Criteria:

          -  Untreated active metastatic disease to the central nervous system (new or enlarging
             lesions on CT or MRI), or within 3 months of treatment (i.e. surgery or radiotherapy)
             for brain metastases. Primary central nervous system tumour (e.g. Glioblastoma
             Multiforme) is not an exclusion criterion.

          -  Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding
             disorders.

          -  Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6
             weeks for nitrosoureas).

          -  Clinically significant cardiac disease (New York Heart Association Class III/IV).

          -  Other malignancy within 3 years prior to entry into the study, except for treated
             non-melanoma skin cancer and cervical carcinoma in situ.

          -  Mental impairment that may compromise the ability to give informed consent and comply
             with the requirements of the study.

          -  Lack of availability for immunological and clinical follow-up assessments.

          -  Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to enrollment.

          -  Pregnancy or breastfeeding.

          -  Women of childbearing potential: Refusal or inability to use effective means of
             contraception.

          -  Concomitant treatment with systemic corticosteroids except for patients with
             Glioblastoma. (Topical or inhalational corticosteroids are permitted.)

          -  Prior administration of monoclonal antibody or antibody fragment, and positive human
             anti-chimeric antibody (HACA) titre.