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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evorpacept | Drug | Fusion protein that blocks CD47-SIRPalpha pathway |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Massachusett's General |
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| Enfortumab Vedotin | Drug | Nectin-4 directed antibody and microtubule inhibitor conjugate |
|
|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| West Clinic | Germantown | Tennessee | 38138 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000712178 | ALX148 |
| C000632577 | enfortumab vedotin |
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