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A Phase I Dose-Escalation Study of BIBH-1 in Patients With Advanced or Metastatic Fibroblast Activation Protein-Positive Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody F19 in treating patients who have advanced or metastatic 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Ludwig Institute for Cancer Research-Sydney Branch
Sydney, New South Wales, Australia
Start Date
November 1, 1998
Primary Completion Date
July 1, 2001
Completion Date
December 1, 2009
Last Updated
July 18, 2013
24
ESTIMATED participants
monoclonal antibody F19
BIOLOGICAL
iodine I 131 monoclonal antibody F19
RADIATION
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
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