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Completed

NCT Number: NCT05524545

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

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.

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Key information

Conditions

Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Preexisting sensory or motor neuropathy Grade ≥2.
  • Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
  • 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.
  • 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.

Treatment and study plan

evorpacept

Drug

Fusion protein that blocks CD47-SIRPalpha pathway

Other names: ALX148

Enfortumab vedotin

Drug

Nectin-4 directed antibody and microtubule inhibitor conjugate

Other names: PADCEV

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)

    Time frame: Up to 15 months

    To identify the RP2D of ALX148 in combination with enfortumab vedotin

Sponsors and collaborators

Lead sponsor

ALX Oncology Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2022
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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