A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- ALX Oncology Inc.
- Enrollment
- 189
- Locations
- 52
- Primary Endpoint
- Objective response rate per RECIST 1.1
Study Overview
Brief Summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Detailed Description
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (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) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with 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 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 has current pneumonitis.
- •Prior treatment with any anti-CD47 or anti-SIRPα agent.
- •Prior treatment with anti-PD-1 or PD-L1.
Arms & Interventions
evorpacept (ALX148) + pembrolizumab
evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Intervention: evorpacept (Drug)
evorpacept (ALX148) + pembrolizumab
evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Intervention: pembrolizumab (Drug)
pembrolizumab
pembrolizumab 200 mg IV given every 3 weeks.
Intervention: pembrolizumab (Drug)
Outcomes
Primary Outcomes
Objective response rate per RECIST 1.1
Time Frame: Last randomized patient reaching at least 24 weeks of follow-up
Secondary Outcomes
- Progression-free survival(Up to 36 months)
- Duration of response(Up to 36 months)
- Overall survival(Up to 36 months)
- Adverse events(Up to 36 months)