Back to Clinical Trials

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

Primary Outcome 2 - Timeframe: Up to 24 months

Primary Outcome 3 - Measure: frequency

Primary Outcome 3 - Timeframe: N/A

Primary Outcome 4 - Measure: severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0))

Primary Outcome 4 - Timeframe: N/A

Primary Outcome 5 - Measure: timing

Primary Outcome 5 - Timeframe: N/A

Primary Outcome 6 - Measure: seriousness

Primary Outcome 6 - Timeframe: N/A

Primary Outcome 7 - Measure: and relationship to study therapy

Primary Outcome 7 - 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: [email protected]

LOCATION

Facility Status Contact
Facility: Moffitt Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact: N/A
Facility: Massachusett's General
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: N/A
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: N/A
Facility: University of North Carolina
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: N/A
Facility: Oregon Health & Science University
Portland, Oregon 97239
United States
Status: Recruiting Contact: N/A
Facility: West Clinic
Germantown, Tennessee 38138
United States
Status: Recruiting Contact: N/A
Facility: UT Southwestern
Dallas, Texas 75390
United States
Status: Recruiting Contact: N/A
Facility: Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: N/A