Bladder Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05524545

Recruitment Status:

Recruiting

Sponsor:

ALX Oncology Inc.

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There are 9 Locations for this study

See Locations Near You

Moffitt Cancer Center
Tampa Florida, 33612, United States
University of Chicago Medicine
Chicago Illinois, 60637, United States
Massachusett's General
Boston Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
West Clinic
Germantown Tennessee, 38138, United States
UT Southwestern
Dallas Texas, 75390, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05524545

Recruitment Status:

Recruiting

Sponsor:


ALX Oncology Inc.

How clear is this clinincal trial information?

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