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
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|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Urothelial Carcinoma||Drug: Evorpacept Drug: Enfortumab Vedotin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Fusion protein that blocks CD47-SIRPalpha pathway
Other Name: ALX148
Drug: Enfortumab Vedotin
Nectin-4 directed antibody and microtubule inhibitor conjugate
Other Name: PADCEV
- First Cycle Dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
- Must have received prior treatment with an immune checkpoint inhibitor (CPI).
- Subjects must have received prior treatment with platinum-containing chemotherapy.
- Subjects must have had progression or recurrence of urothelial cancer.
- Subjects must have measurable disease according to RECIST (Version 1.1).
- Adequate bone marrow function.
- Adequate renal function.
- Adequate liver function.
- Adequate Eastern Cooperative Oncology Group (ECOG) performance status.
- Preexisting sensory or motor neuropathy Grade ≥2.
- Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
- Prior treatment with enfortumab vedotin or other monomethylauristatin (MMAE)-based antibody-drug conjugate (ADCs)
- Prior treatment with any anti-CD47 or anti-signal regulatory protein-α (SIRPα) agent.
- Known active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated.
- History of uncontrolled diabetes mellitus within 3 months of the first dose of study drug.
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
|Contact: Haiying (Harry) Liu, MD, MPH, MBAfirstname.lastname@example.org|
|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|
|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|
|Responsible Party:||ALX Oncology Inc.|
|Other Study ID Numbers:||
|First Posted:||September 1, 2022 Key Record Dates|
|Last Update Posted:||January 25, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type