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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05524545
Recruitment Status : Recruiting
First Posted : September 1, 2022
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
ALX Oncology Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Urothelial Carcinoma Drug: Evorpacept Drug: Enfortumab Vedotin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 2, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Evorpacept (ALX148) + Enfortumab Vedotin

Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks.

Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle.

 Drug: Evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
Other Name: ALX148

Drug: Enfortumab Vedotin
Nectin-4 directed antibody and microtubule inhibitor conjugate
Other Name: PADCEV


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05524545


Contacts
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Contact: Haiying (Harry) Liu, MD, MPH, MBA 650-466-7125 info@alxoncology.com

Locations
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United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Medicine Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Massachusett's General Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
West Clinic Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
UT Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
United States, Washington
Seattle Cancer Care Alliance Not yet recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
ALX Oncology Inc.
More Information
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Responsible Party: ALX Oncology Inc.
ClinicalTrials.gov Identifier: NCT05524545    
Other Study ID Numbers: ASPEN-07
First Posted: September 1, 2022    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms