The purpose of this multi-center, first-time-in-human, Phase I trial is to enroll patients with advanced solid tumors who have failed standard therapy.
Patients will receive four weekly doses of FP-1039 by intravenous administration to characterize the safety and tolerability of FP-1039. Additionally, the pharmacokinetics and preliminary anti-tumor activity of FP-1039 will be assessed in the study.
FP-1039 is an FGFR1:Fc fusion protein shown in preclinical studies to inhibit angiogenesis and slow the growth of tumors.
Lewis Williams, executive chairman and founder of FivePrime, said: “We are excited to begin clinical testing of FP-1039, a biologic that may have broad potential application in cancer treatment.
“This is our first protein therapeutic to enter clinical development and represents a major milestone for FivePrime. Our preclinical studies suggest FP-1039 will block both cancer cell proliferation and tumor angiogenesis.”