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CompletedNCT05524545Updated Jul 25, 2025

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

A Phase 1 interventional study of Evorpacept and Enfortumab Vedotin in Bladder Cancer and Urothelial Carcinoma, sponsored by ALX Oncology Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by ALX Oncology Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bladder Cancer
  • Urothelial Carcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Evorpacept (ALX148) + 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.

    Drug: Evorpacept · Drug: Enfortumab Vedotin

Interventions

  • DrugEvorpacept

    Fusion protein that blocks CD47-SIRPalpha pathway

    Also known as: ALX148

  • DrugEnfortumab Vedotin

    Nectin-4 directed antibody and microtubule inhibitor conjugate

    Also known as: PADCEV

05

What researchers measure

Primary outcomes

  1. First Cycle Dose limiting toxicities (DLTs)

    Time frame: Up to 28 days

  2. 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

    Time frame: Up to 24 months

  3. Phase 1: Recommended Phase 2 Dose (RP2D)

    To identify the RP2D of ALX148 in combination with enfortumab vedotin

    Time frame: Up to 15 months

06

Study locations

8 sites
  • Moffitt Cancer Center
    Tampa, Florida 33612, 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
07

Registry details

Key details

Study ID
NCT05524545
Lead sponsor
ALX Oncology Inc.
Responsible party
Sponsor
First posted
Sep 1, 2022
Start date
Nov 2, 2022
Primary completion
Jun 27, 2025
Completion
Jun 27, 2025
Last update
Jul 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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