Clinical trial NCT02209727: Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Official title: A Phase I Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Determination of the dose limiting toxicity (DLT)
timeFrame: up to 12 weeks
measure: Determination of the maximum tolerated dose (MTD)
timeFrame: up to 12 weeks
measure: Occurrence of toxicity
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria
timeFrame: 8 weeks after therapeutic infusion
Other outcomes:
Locations:
Study officials:
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