The purpose of this study is to evaluate the safety and tolerability of SF1126 in patients with advanced or metastatic tumors by assessing the dose limiting toxicities (DLTs) and defining the maximum tolerated dose given twice per week for 4 weeks and ultimately define a recommended phase II dose.
SF1126 is a conjugate containing a vascular targeted pan-PI3K inhibitor that selectively inhibits all PI3K class I isoforms and other key members of the PI3K superfamily, including mTORC1/2, DNA-PK, PLK-1, CK2, ATM and PIM-1. SF1126 is designed to inhibit both angiogenesis and cell proliferation by targeting and binding to specific integrins such as αγβ3 that are expressed on the surface of new tumor vasculature and within the tumor compartment. In preclinical xenograft models SF1126 has demonstrated broad activity as a single agent; synergy with commonly used chemotherapy agents, targeted agents, and radiation; and has been shown to reverse resistance mediated through the PI3K/PTEN pathway.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Dose Escalating with 3+ patients in each cohort
Scottsdale Clinical Research Institute
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
To assess the dose limiting toxicities (DLTs) of SF1126 and the maximum tolerated dose given twice per week for 4 weeks and ultimately define a recommended phase II dose.
Time frame: Assessed at each visit and end of cycle 1
To assess any preliminary evidence of anti-tumor activity observed with SF1126
Time frame: Through study completion or early study discontinuation
To characterize the pharmacokinetics following the IV doses on Days 1 and 28
Time frame: Cycle 1 Days 1 and 28
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