Brief Title: Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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: Haiying (Harry) Liu, MD, MPH, MBA

Phone: 650-466-7125

Email: info@alxoncology.com

LOCATION