Clinical trial · Interventional
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)
NCT05524545CI-TRIAL-00092623completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enfortumab Vedotin | Drug | Enfortumab Vedotin | ALIAS |
| Evorpacept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Evorpacept (ALX148) + Enfortumab Vedotin
- description
- Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks. Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle.
- interventionNames
- Drug: Evorpacept
- Drug: Enfortumab Vedotin
Primary outcomes (3)
- measure
- First Cycle Dose limiting toxicities (DLTs)
- timeFrame
- Up to 28 days
- measure
- 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
- timeFrame
- Up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.