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

Bladder Cancer Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524545
• Other study ID #: ASPEN-07
• Status: Recruiting
• Phase: Phase 1
• Start date: November 2, 2022
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: ALX Oncology Inc.
• Contact: Haiying (Harry) Liu, MD, MPH, MBA
• Phone: 650-466-7125
• Email: info[@]alxoncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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-a (SIRPa) 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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• Evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
• Enfortumab Vedotin
Nectin-4 directed antibody and microtubule inhibitor conjugate

Locations

Country	Name	City	State
United States	Massachusett's General	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Chicago Medicine	Chicago	Illinois
United States	UT Southwestern	Dallas	Texas
United States	West Clinic	Germantown	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ALX Oncology Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Cycle Dose limiting toxicities (DLTs)		Up to 28 days
Primary	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