Description:
A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Not yet recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
ALX148 | ALX148 + Pembrolizumab | |
Pembrolizumab | Keytruda | ALX148 + Pembrolizumab |
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.
Name | Type | Description | Interventions |
---|---|---|---|
ALX148 + Pembrolizumab | Experimental | ALX148 45 mg/kg IV and pembrolizumab 200mg IV given every 3 weeks. |
|
Pembrolizumab | Active Comparator | Pembrolizumab 200mg IV given every 3 weeks. |
|
Inclusion Criteria: - metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior systemic therapy for their advanced disease. . - Adequate Bone Marrow Function. - Adequate Renal & Liver Function. - Adequate Performance Status Exclusion Criteria: - Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids. - History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Prior treatment with any anti-CD47 or anti-SIRPα agent. - Prior treatment with anti-PD-1 or PD-L1.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Objective response rate per RECIST 1.1 |
Time Frame: | Last randomized patient reaching at least 24 weeks of follow-up. |
Safety Issue: | |
Description: |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | ALX Oncology Inc. |
January 19, 2021