Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Sponsor: ALX Oncology Inc.
ClinicalTrials ID:NCT04675333
This Phase 2 open-label, randomized study evaluates the anti-tumor efficacy of evorpacept combined with pembrolizumab and chemotherapy in patients with untreated metastatic or unresectable recurrent HNSCC. Participants must have adequate bone marrow, renal, and liver function, and an appropriate ECOG status. Interventions include IV administration of evorpacept, pembrolizumab, and platinum-based chemotherapy every three weeks.
Patient Parameters
| Parameter | Options |
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Program Overview
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Description
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.
Eligibility Criteria
Inclusion Criteria
- Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
- Adequate bone marrow function.
- Adequate renal and liver function.
- Adequate ECOG performance status.
Exclusion Criteria
- Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
- History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Prior treatment with any anti-CD47 or anti-SIRPα agent.
- Prior treatment with anti-PD-1 or PD-L1.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hoag Hospital | 92618 | Irvine | California |
| University of California San Diego | 92037 | La Jolla | California |
| Cedar Sinai Medical Center | 90048 | Los Angeles | California |
| University of Miami, Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Rush University Medical Center | 60612 | Chicago | Illinois |
| University of Louisville | 40202 | Louisville | Kentucky |
| University of Maryland Medical System | 21201 | Baltimore | Maryland |
| Memorial Sloan Kettering | 10021 | New York | New York |
| The Ohio State University | 43235 | Columbus | Ohio |
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