A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)
Completed · Phase 1
Conditions studied: Bladder Cancer, Urothelial Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05524545
- Run by
- ALX Oncology Inc.
- People needed
- 36
- Starts
- 2022-11-02
- Expected to finish
- 2025-06-27
- Last updated by the study team
- 2025-07-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
- Must have received prior treatment with an immune checkpoint inhibitor (CPI).
- Subjects must have received prior treatment with platinum-containing chemotherapy.
- Subjects must have had progression or recurrence of urothelial cancer.
- Subjects must have measurable disease according to RECIST (Version 1.1).
- Adequate bone marrow function.
- Adequate renal function.
- Adequate liver function.
- Adequate Eastern Cooperative Oncology Group (ECOG) performance status.
You may not qualify if…
- Preexisting sensory or motor neuropathy Grade ≥2.
- Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
- Prior treatment with enfortumab vedotin or other monomethylauristatin (MMAE)-based antibody-drug conjugate (ADCs)
- Prior treatment with any anti-CD47 or anti-signal regulatory protein-α (SIRPα) agent.
- Known active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated.
- History of uncontrolled diabetes mellitus within 3 months of the first dose of study drug.
Where it is running
- 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
- 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
Full record on ClinicalTrials.gov
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