A Phase I Dose-Escalation Study of BIBH-1 in Patients With Advanced or Metastatic Fibroblast Activation Protein-Positive Cancer
OBJECTIVES: I. Identify the toxicity associated with increasing doses of monoclonal antibody
F19 (BIBH-1) administered weekly by intravenous infusion in patients with unresectable,
advanced or metastatic fibroblast activation protein-positive colorectal cancer. II.
Determine the dose limiting toxicity and maximum tolerated dose of this drug in these
patients. III. Measure induction titers of human anti-human antibody to BIBH-1 and correlate
immunologic-related clinical effects. IV. Determine the pharmacokinetics, biodistribution,
and imaging characteristics of increasing intravenous doses of the drug. V. Document tumor
responses in this patient population.
OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive
monoclonal antibody F19 (BIBH-1) IV over 60 minutes weekly for 12 weeks. The first, fifth,
and ninth treatments are combined with iodine I 131. Patients with stable or responding
disease may continue treatment for up to 12 months. The dose of BIBH-1 is escalated in
cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
limiting toxicity. Patients are followed at 1 month.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 8 months.
Primary Purpose: Treatment
Sydney Welt, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|