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Trial Title:
A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)
NCT ID:
NCT05524545
Condition:
Bladder Cancer
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Evorpacept
Description:
Fusion protein that blocks CD47-SIRPalpha pathway
Arm group label:
Evorpacept (ALX148) + Enfortumab Vedotin
Other name:
ALX148
Intervention type:
Drug
Intervention name:
Enfortumab Vedotin
Description:
Nectin-4 directed antibody and microtubule inhibitor conjugate
Arm group label:
Evorpacept (ALX148) + Enfortumab Vedotin
Other name:
PADCEV
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.
Criteria for eligibility:
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.
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medicine
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Massachusett's General
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
West Clinic
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Recruiting
Facility:
Name:
UT Southwestern
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Seattle Cancer Care Alliance
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Start date:
November 2, 2022
Completion date:
April 2025
Lead sponsor:
Agency:
ALX Oncology Inc.
Agency class:
Industry
Source:
ALX Oncology Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524545
