NCT05524545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2022

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

August 30, 2022

Last Update Submit

July 22, 2025

Conditions

Bladder CancerUrothelial Carcinoma

Outcome Measures

Primary Outcomes (3)

  • First Cycle Dose limiting toxicities (DLTs)

    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

    Up to 24 months

  • Phase 1: Recommended Phase 2 Dose (RP2D)

    To identify the RP2D of ALX148 in combination with enfortumab vedotin

    Up to 15 months

Study Arms (1)

Evorpacept (ALX148) + Enfortumab Vedotin

EXPERIMENTAL

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: EvorpaceptDrug: Enfortumab Vedotin

Interventions

EvorpaceptDRUG

Fusion protein that blocks CD47-SIRPalpha pathway

Also known as: ALX148
Evorpacept (ALX148) + Enfortumab Vedotin
Enfortumab VedotinDRUG

Nectin-4 directed antibody and microtubule inhibitor conjugate

Also known as: PADCEV
Evorpacept (ALX148) + Enfortumab Vedotin

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Massachusett's General

Boston, Massachusetts, 02114, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

West Clinic

Germantown, Tennessee, 38138, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsCarcinoma, Transitional Cell

Interventions

ALX148enfortumab vedotin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 1, 2022

Study Start

November 2, 2022

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations

US(8)