AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Fusion protein that blocks CD47-SIRPalpha pathway
Nectin-4 directed antibody and microtubule inhibitor conjugate
Moffitt Cancer Center
Tampa, Florida, United States
Massachusett's General
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
First Cycle Dose limiting toxicities (DLTs)
Time frame: Up to 28 days
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0)), timing, seriousness, and relationship to study therapy
Time frame: Up to 24 months
Phase 1: Recommended Phase 2 Dose (RP2D)
To identify the RP2D of ALX148 in combination with enfortumab vedotin
Time frame: Up to 15 months
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Oregon Health & Science University
Portland, Oregon, United States
West Clinic
Germantown, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States