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Brief Title: 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)

INTRODUCTION

  • Org Study ID: ASPEN-07
  • Secondary ID: N/A
  • NCT ID: NCT05524545
  • 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.

  • Overall Status
    Recruiting
  • Start Date
    November 2, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: First Cycle Dose limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: Up to 28 days

Primary Outcome 2 - 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

Primary Outcome 2 - Timeframe: Up to 24 months

CONDITION

  • Bladder Cancer
  • Urothelial Carcinoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 650-466-7125

Email: info@alxoncology.com

LOCATION

Facility Status Contact

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