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Clinical Trials in South Korea / NCT04675294
Active, not recruiting Phase 2

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

NCT04675294 · tracked via the Priya Life Science South Korea tracker
Sponsor
ALX Oncology Inc
Phase
Phase 2
Started
2021-04-02
Last updated
2025-08-01

Condition(s) studied

Head and Neck CancerHead and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

evorpacept →pembrolizumab →

evorpacept: IV Q3W

pembrolizumab: IV Q3W

Study summary

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
Hoag Hospital Irvine California
University of California San Diego La Jolla California
H. Lee Moffitt Cancer Center Tampa Florida
Northwest Georgia Oncology Centers Marietta Georgia
Rush University Medical Center Chicago Illinois
Blessing Cancer Center Quincy Illinois
University of Maryland Medical System Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Rutgers Cancer Institute of New Jersey Newark New Jersey
Memorial Sloan-Kettering Cancer Center Long Island City New York
The Ohio State University Columbus Ohio
Oregon Health & Science University Portland Oregon
Vanderbilt - Ingram Cancer Center Nashville Tennessee
Houston Methodist Cancer Center Houston Texas
St. Vincent's Sydney New South Wales
Royal Brisbane and Womens Hospital Brisbane Queensland
Peter MacCallum Cancer Centre Melbourne Victoria
Sir Charles Gairdner Hospital Perth Western Australia
Ashford Cancer Centre Research Windsor Gardens Australia
Cliniques Universitaires Saint-Luc Brussels Belgium
AZ Groeninge Kortrijk Belgium
UZ Leuven Leuven Belgium
Hamilton Health Sciences - Juravinski Cancer Centre Hamilton Ontario
LHSC - Victoria Hospital London Ontario
Ottawa Hospital Cancer Centre Ottawa Ontario
Princess Margaret Cancer Centre Toronto Ontario
VUMC Goederenontvangst Amsterdam Netherlands
Universitair Medisch Centrum Groningen Groningen Netherlands
National University Cancer Institute Singapore Singapore
National Cancer Centre Singapore Singapore Singapore
Chungbuk National University Hospital Cheongju-si South Korea
Yeungnam University Medical Center Daegu South Korea
Chungnam National University Hospital Daejeon South Korea
CHA University of Bundang Gyeonggi-do South Korea
Gachon University - Gil Medical Center Incheon South Korea
Seoul National University Bundang Hospital Seongnam South Korea
Korea University Medical Center (KUMC) - Korea University Anam Hospital Seoul South Korea
Seoul National University Hospital Seoul South Korea
The Catholic University of Korea - Eunpyeong St. Mary's Hospital Seoul South Korea
Samsung Medical Center Seoul South Korea

+ 13 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More ALX Oncology Inc. trials in South Korea

ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer Recruiting
A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) Active, not recruiting
Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) Active, not recruiting

Other trials for the same condition

Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination Active, not recruiting
Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors Recruiting
A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone Active, not recruiting
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors Recruiting
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04675294 on ClinicalTrials.gov ↗ ← All trials in South Korea