Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Lung Neoplasms

Treatments

Drug: BIBH 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT02199886

1152.3

Details and patient eligibility

About

Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in tumour to that of normal tissue in patients with non-small cell lung cancer and to measure human anti-human antibody (HAHA) concentrations.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed primary or secondary advanced non-small cell lung cancer
Eligible for a lung biopsy or scheduled for surgery that would provide biopsy material
Karnofsky performance status of ≥ 70
Expected survival of ≥ 3 months
Greater than or equal to 18 years of age
Absolute granulocyte count ≥ 2.5 x 10**9/L
Lymphocyte count > 0.7 x 10**9/L
Platelet count ≥ 100 x 10**9/L
Serum Creatinine ≤ 2.0 mg/dl (0.20 mmol/L)
Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 3x upper limit of normal
Total bilirubin < 2 mg/dl or 34µmol (SI unit equivalent)
Ability to provide written informed consent

Exclusion criteria

Active metastatic disease to the central nervous system, exhibited by new or enlarging lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases
Exposure to an investigational agent within four weeks of the BIBH 1 infusion
Patients that are not fully recovered from surgery. Because of the potential binding of BIBH 1 to healing scars, patients with incomplete healing at an incision site, as evidenced by incomplete granulation, infection or localized edema are excluded
Chemotherapy or immunotherapy within four weeks preceding entry (six weeks for nitrsoureas and/or mitomycin-C.)
Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment
Serious illness: e.g., active infections requiring antibiotics, bleeding disorders or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
Women who are breast-feeding or pregnant
Men and women of childbearing potential who are unwilling to utilize a medically acceptable method of contraception
Previous participation in this study
Patients who have autoimmune disease or hypertopic skin conditions that possibly over-express Fibroblast Activation Protein and may be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis and keloids.
Patients with unstable angina pectoris. Patients prescribed medication to control their angina pectoris must be on a fixed dose for at least 1 month prior to screening to be eligible for the trial.
Patients who experienced a myocardial infarction within 3 months of Screening.