Phase I Study of the Fully Human Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody IMC-11F8 in Patients With Solid Tumors Who Have Failed Standard Therapy
- Histologically-confirmed, EGFR-detectable or EGFR-undetectable,
unidimensionally-measurable and/or evaluable solid tumors who failed standard therapy
or for whom no standard therapy is available. Patients who do not have tissue
available for EGFR testing will undergo a biopsy of an accessible tumor.
- ECOG performance status score of ≤ 2 at study entry.
- Able to provide written informed consent.
- White blood cell (WBC) count ≥ 3 x 109/L; an absolute neutrophil count ≥ 1.5 x 109/L;
a hemoglobin level > 90 g/L; and a platelet count ≥ 100 x 109/L.
- Adequate hepatic function as defined by:
- an alkaline phosphatase level ≤ 5.0 x the ULN
- a bilirubin level ≤ 1.5 x the ULN
- aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x the
ULN or ≤ 5 x the ULN for patients with liver metastases
- Adequate renal function as defined by a serum creatinine level within normal limits.
- Use of effective contraception if procreative potential exists.
- Life expectancy of approximately 3 months in the opinion the opinion of the
- Chemotherapy, radiation, and/or hormonal therapy (except palliative radiation therapy
for disease-related pain and chronic hormonal therapy for prostate carcinoma) within
4 weeks of study entry.
- Concurrent unstable or uncontrolled medical disease (e.g., active uncontrolled
systemic infection, poorly controlled hypertension or history of poor compliance with
an anti-hypertensive regimen, unstable angina, congestive heart failure, uncontrolled
diabetes) or other chronic disease, which, in the opinion of the investigator, could
compromise the patient or the study.
- Newly-diagnosed or symptomatic brain metastases (patients with a history of brain
metastases must have received definitive surgery or radiotherapy, be clinically
stable, and not taking steroids; anticonvulsants are allowed).
- Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the
cervix. Patients with a previous malignancy but without evidence of disease for ≥ 3
years will be allowed to enter the trial.
- Any condition that prevents the patient from providing informed consent.
- Pregnancy (confirmed by serum beta human chorionic gonadotropin [ßHCG]) or
- Any investigational agent(s) or device(s) within 4 weeks of study entry.
- Prior treatment with cetuximab, or any other epidermal growth factor receptor
inhibitors, including tyrosine kinase inhibitors, such as gefitinib or erlotinib.
Prior treatment with other monoclonal antibodies targeting receptors other than the
EGFR is permitted ≥ 4 weeks prior to study entry.
- Any prior therapy that targeted the EGFR or EGFR pathway.
- Known history of human immunodeficiency virus.
- Employees of the investigator or study center with direct involvement in this study
or other studies under the direction of the investigator or study center, as well as
family members of the employees.