Clinical trial · Interventional
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
NCT04675294CI-TRIAL-00092958active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| evorpacept | Drug | — | UNRESOLVED |
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- evorpacept (ALX148) + pembrolizumab
- description
- evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
- interventionNames
- Drug: evorpacept
- Drug: pembrolizumab
- type
- ACTIVE_COMPARATOR
- label
- pembrolizumab
- description
- pembrolizumab 200 mg IV given every 3 weeks.
- interventionNames
- Drug: pembrolizumab
Primary outcomes (1)
- measure
- Objective response rate per RECIST 1.1
- timeFrame
- Last randomized patient reaching at least 24 weeks of follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.