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ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Sponsor: ALX Oncology Inc.
Summary
The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.
Official title: Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-10
Completion Date
2028-12
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Evorpacept (ALX148)
IV infusion
Trastuzumab
IV infusion
Paclitaxel
IV infusion
Capecitabine
Oral administration
Eribulin
IV infusion
Gemcitabine
IV infusion
Vinorelbine
IV infusion
Locations (28)
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, United States
Saint Mary's Regional Hospital - Cancer Centers of Colorado
Grand Junction, Colorado, United States
The George Washington Medical facility Associates
Washington D.C., District of Columbia, United States
City of Hope Chicago
Zion, Illinois, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, United States
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Gabrail Cancer Center
Canton, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Hopital de l'Institut Curie
Paris, France
Hopital Europeen Georges Pompidou (HEGP)
Paris, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France
Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia
Novara, Italy
National Cancer Centre Singapore
Singapore, Singapore
Inha University Hospital
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Universitari Arnau de Villanova
Lleida, Catalonia, Spain
Barts Health NHS Trust - St Bartholomew's Hospital
London, Greater London, United Kingdom