Bladder Cancer, Urothelial Carcinoma
Conditions
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.
Interventions
DRUGEvorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
DRUGEnfortumab Vedotin
Nectin-4 directed antibody and microtubule inhibitor conjugate
Sponsors
ALX Oncology Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to 15 months | To identify the RP2D of ALX148 in combination with enfortumab vedotin |
Countries
United States
Outcome results
None listed