NCT04675294Active, not recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 1 Aug 2025
Brief summary (registry, in English)
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 189 (actual)
- First submitted
- 15 Dec 2020
- Start date
- 2 Apr 2021
- Primary completion date
- 3 Mar 2025
- Lead sponsor
- ALX Oncology Inc.
- Diseases
- Head and neck cancer
- NCT number
- NCT04675294
- EU CT number
- 2023-508340-22-00
- EudraCT number
- 2020-004093-21
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 189
- From 2 Apr 2021 to the primary completion date, 3 Mar 2025
- 53 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any anti-CD47 or anti-SIRPα agent.
- Prior treatment with anti-PD-1 or PD-L1.
Other illness
- Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Brisbane and Womens Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| St. Vincent's Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Ashford Cancer Centre Research Coordinator of this site? Confirm its status | Windsor Gardens | Australia | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Hamilton Health Sciences-Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| LHSC Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Institud Catala d´Oncologia Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Dexeus Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Severo Ochoa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Yeungnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| CHA University of Bundang Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Medical Center (KUMC) - Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital Yonsei University Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| SNU Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Catholic University of Korea, St. Vincent's Hospital Suwon Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Yonsei University Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| VUMC Goederenontvangst Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| National University Cancer Institute Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National Cancer Centre Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| University of Maryland Medical System Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Houston Methodist Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Hoag Hospital Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center Coordinator of this site? Confirm its status | Long Island City | United States | Unknown status |
| Northwest Georgia Oncology Centers Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Blessing Cancer Center Coordinator of this site? Confirm its status | Quincy | United States | Unknown status |
| H Lee Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.