NCT05524545CompletedPhase 1
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)
Source: ClinicalTrials.gov · Last updated 25 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 30 Aug 2022
- Start date
- 2 Nov 2022
- Primary completion date
- 27 Jun 2025
- Lead sponsor
- ALX Oncology Inc.
- Diseases
- Bladder cancer
- NCT number
- NCT05524545
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- From 2 Nov 2022 to the primary completion date, 27 Jun 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Preexisting sensory or motor neuropathy Grade ≥2.
- Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusett's General Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UT Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| West Clinic Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.