Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.
The purpose of the dose escalation phase of the study is to determine the maximum tolerated dose/Phase 2 recommended dose of NEOD001 when given as a single agent intravenously in approximately 30 subjects with AL amyloidosis. The purpose of the expansion phase of the study is to evaluate the safety, preliminary efficacy and pharmacokinetics of single agent NEOD001 at the maximum tolerated dose/Phase 2 recommended dose in approximately 25 additional evaluable subjects.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Monoclonal antibody administered by intravenous infusion every 28 days.
Stanford University Cancer Center
Palo Alto, California, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Safety and tolerability
* Adverse event profile * Dose limiting toxicity and maximum tolerated dose
Time frame: 28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator
Maximum tolerated dose
* Adverse event profile * Dose Limiting Toxicity and maximum tolerated dose
Time frame: 28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator
Pharmacokinetics
• Pharmacokinetic parameters including Cmax, Tmax, AUC, Cav, Cmin, t½, CL, and Vz
Time frame: 28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator
Immunogenicity
• Measurement of anti-NEOD001 antibodies
Time frame: 28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States