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

Primary Purpose

Bladder Cancer, Urothelial Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Evorpacept
Enfortumab Vedotin
Sponsored by
ALX Oncology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Moffitt Cancer CenterRecruiting
  • University of Chicago Medicine
  • Massachusett's GeneralRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of North CarolinaRecruiting
  • Oregon Health & Science UniversityRecruiting
  • West ClinicRecruiting
  • UT SouthwesternRecruiting
  • Seattle Cancer Care AllianceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evorpacept (ALX148) + Enfortumab Vedotin

Arm Description

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.

Outcomes

Primary Outcome Measures

First Cycle Dose limiting toxicities (DLTs)
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

Secondary Outcome Measures

Full Information

First Posted
August 30, 2022
Last Updated
September 1, 2023
Sponsor
ALX Oncology Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05524545
Brief Title
A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALX Oncology Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Urothelial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evorpacept (ALX148) + Enfortumab Vedotin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Evorpacept
Other Intervention Name(s)
ALX148
Intervention Description
Fusion protein that blocks CD47-SIRPalpha pathway
Intervention Type
Drug
Intervention Name(s)
Enfortumab Vedotin
Other Intervention Name(s)
PADCEV
Intervention Description
Nectin-4 directed antibody and microtubule inhibitor conjugate
Primary Outcome Measure Information:
Title
First Cycle Dose limiting toxicities (DLTs)
Time Frame
Up to 28 days
Title
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

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiying (Harry) Liu, MD, MPH, MBA
Phone
650-466-7125
Email
info@alxoncology.com
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Massachusett's General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
West Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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