Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• Evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and at least one previous conventional treatment for advanced disease

• Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1

• Measurable or evaluable disease, determined by World Health Organization (WHO) criteria using standard imaging modalities, including ultrasound, X-ray, CT and/or Magnetic Resonance Imaging (MRI). Bone scans and/or antibody scans are not to be used to determine the extent of the disease

• Expected survival of ≥ 16 weeks

• At least 18 years of age

• Platelet count ≥ 100 x 10**9/L

• Absolute neutrophil count ≥ 2.0 x 10**9/L

• Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal or < 5 x upper limit of normal if liver metastases are present

• Total bilirubin ≤ 2mg/dL

• Serum creatinine ≤ 2mg/dL

• Ability to provide written informed consent

Exclusion Criteria:

• Known brain metastases

• Exposure to an investigational agent within 30 days prior to receiving the scout dose

• Incomplete recovery from surgery or incomplete healing of an incision site or evidence of infection

• Treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within the 30 days (42 days for nitrosoureas and/or mitomycin C) of the scout infusion. Patients using inhaled corticosteroids are considered eligible for enrollment

• Serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders or other serious illnesses precluding the use of either 131I or sibrotuzumab

• Women who are breast-feeding or pregnant

• Men and women who were sexually active and are unwilling to utilize a medically acceptable method of contraception

• Hypertrophic skin disease or autoimmune disease that possibly involves over-expression of fibroblast activation protein (FAP), which can be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis, and keloids

• Unstable angina pectoris. Patients prescribed medication to control their angina pectoris must have been on a fixed dose for at least 1 month prior to screening to be eligible for trial enrollment

• Myocardial infarction within 3 months prior to screening

• New York Heart Association (NYHA) Heart failure stage III or IV, or a left ventricular ejection fraction of ≤ 40 %

• Impaired lung function, measured by a decrease in forced expiratory volume at one second (FEV1) to less than 50 % of the predicted normal value