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

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: 131I-Sibrotuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02209727

1152.6

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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