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

Phase 1

Active, not recruiting

• Conditions: Bladder Cancer; Urothelial Carcinoma
• Interventions: Drug: Evorpacept; Drug: Enfortumab Vedotin

• Registration Number: NCT05524545
• Lead Sponsor: ALX Oncology Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Study Start: 2022-11-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-06-16
• Study Completion: 2025-08-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evorpacept (ALX148) + Enfortumab Vedotin	Evorpacept	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.
Evorpacept (ALX148) + Enfortumab Vedotin	Enfortumab Vedotin	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.

Primary Outcome Measures

Name	Time	Method
First Cycle Dose limiting toxicities (DLTs)	Up to 28 days
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	Up to 24 months
Phase 1: Recommended Phase 2 Dose (RP2D)	Up to 15 months	To identify the RP2D of ALX148 in combination with enfortumab vedotin

Trial Locations

Locations (8)

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