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

Last updated: May 7, 2025
Sponsor: ALX Oncology Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Urothelial Carcinoma

Bladder Cancer

Carcinoma

Treatment

Evorpacept

Enfortumab Vedotin

Clinical Study ID

NCT05524545
ASPEN-07
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed, unresectable locally advanced or metastatic urothelialcarcinoma.

  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

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)-basedantibody-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 punctatekeratitis are allowed if the disorder is being adequately treated.

  6. History of uncontrolled diabetes mellitus within 3 months of the first dose of studydrug.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Evorpacept
Phase: 1
Study Start date:
November 02, 2022
Estimated Completion Date:
August 29, 2025

Connect with a study center

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Massachusett's General

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • West Clinic

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Site Not Available

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