A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)

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 (ASPEN-07)

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.

Inclusion Criteria:

1. Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
2. Must have received prior treatment with an immune checkpoint inhibitor (CPI).
3. Subjects must have received prior treatment with platinum-containing chemotherapy.
4. Subjects must have had progression or recurrence of urothelial cancer.
5. Subjects must have measurable disease according to RECIST (Version 1.1).
6. Adequate bone marrow function.
7. Adequate renal function.
8. Adequate liver function.
9. Adequate Eastern Cooperative Oncology Group (ECOG) performance status.

Exclusion Criteria:

1. Preexisting sensory or motor neuropathy Grade ≥2.
2. Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
3. Prior treatment with enfortumab vedotin or other monomethylauristatin (MMAE)-based antibody-drug conjugate (ADCs)
4. Prior treatment with any anti-CD47 or anti-signal regulatory protein-α (SIRPα) agent.
5. Known active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated.
6. History of uncontrolled diabetes mellitus within 3 months of the first dose of study drug.