ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie zaawansowany rak piersi HER2-dodatni
- •Co najmniej jedno poprzednie leczenie, w tym lek T-DXd (ENHERTU)
- •Progresja choroby po ostatnim leczeniu
- •Możliwość otrzymywania jednego z dostępnych chemioterapeutyków (kapecytabina, eribulina, gemcytabina, paklitaksel lub winorelbin)
- •Mierzalne ogniska nowotworu
- •Frakcja wyrzutowa lewej komory serca ≥50%
- •Sprawność ogólna oceniana na 0-1 w skali ECOG
- •Spodziewana długość życia co najmniej 3 miesiące
✗ Disqualifies
- •Przerzuty do mózgu, chyba że leczone i stabilne
- •Poprzednie leczenie lekami anty-CD47 lub anty-SIRPα
- •Przeciwwskazania do otrzymywania trastuzumabu
- •Pełny niedobór enzymu DPD lub poważne działania niepożądane po wcześniejszej chemioterapii opartej na 5FU
- •Niedostateczny czas od ostatniego leczenia przeciwnowotworowego
- •Historia autoimmunologicznej niedokrwistości hemolitycznej lub niedokrwistości autoimmunologicznej
- •Przeszczep tkanki lub organu
- •Aktywna, niestabilna choroba sercowo-naczyniowa
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 5, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (44)
The University of Arizona Cancer Center - North Campus
Tucson, United States
City of Hope
Duarte, United States
UC San Diego Moores Cancer Center
La Jolla, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, United States
Lutheran Hospital - Cancer Centers of Colorado
Golden, United States
Saint Mary's Regional Hospital - Cancer Centers of Colorado
Grand Junction, United States
The George Washington Medical facility Associates
Washington D.C., United States
Sylvester Comprehensive Cancer Center
Miami, United States
City of Hope Chicago
Zion, United States
University of Michigan Rogel Cancer Center
Ann Arbor, United States
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, United States
St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, United States
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Gabrail Cancer Center
Canton, United States
University of Texas Southwestern Medical Center
Dallas, United States
Houston Methodist Cancer Center
Houston, United States
The University of Texas M.D. Anderson Cancer Center
Houston, United States
Virginia Cancer Specialists
Fairfax, United States
Fred Hutchinson Cancer Center
Seattle, United States
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada
Hopital de l'Institut Curie
Paris, France
Hopital Europeen Georges Pompidou (HEGP)
Paris, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France
Centre Eugene Marquis
Rennes, France
Azienda Ospedaliero Universitaria delle Marche
Torrette, Italy
IRCCS Azienda Ospedaliera Metropolitana
Genova, Italy
Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia
Novara, Italy
National Cancer Centre Singapore
Singapore, Singapore
Curie Oncology - Farrer
Singapore, Singapore
Inha University Hospital
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitari Arnau de Villanova
Lleida, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Beata Maria Ana
Madrid, Spain
Barts Health NHS Trust - St Bartholomew's Hospital
London, United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, United Kingdom
Trial contact
Cheng Quah, MD
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.