Actively Recruiting
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Led by ALX Oncology Inc. · Updated on 2026-04-13
120
Participants Needed
32
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Histologically confirmed invasive HER2+ breast cancer.
-
Received at least one prior line of therapy including T-DXd (ENHERTU) for locally advanced/metastatic HER2+ breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease. Participants who discontinue T-DXd due to intolerance are considered eligible.
-
Progressed on or following the most recent line of therapy.
-
Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine).
-
Measurable disease as defined by RECIST v1.1.
-
LVEF ≥50%.
-
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.
-
Life expectancy of at least 3 months.
-
Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
-
Adequate liver function:
- Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome);
- Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).
-
Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible and which do not constitute a safety risk by Investigator judgment.
You will not qualify if you...
-
Participants with known CNS metastases unless treated and stable prior to enrollment.
-
Prior exposure to any anti-CD47 or anti-SIRPα agent.
-
Any condition that would be contraindicated to receiving trastuzumab
-
Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen
-
Following anti-cancer therapy with insufficient washout before start of treatment:
- chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of start of treatment.
- Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of start of treatment).
-
History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.
-
Had an allogeneic tissue/solid organ transplant.
-
Any active, unstable cardiovascular disease.
-
Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).
-
Has an active autoimmune disease that has required systemic treatment in past 2 years.
-
Other primary malignancy within 2 years.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States, 80218
Actively Recruiting
4
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, United States, 80401
Actively Recruiting
5
Saint Mary's Regional Hospital - Cancer Centers of Colorado
Grand Junction, Colorado, United States, 81501
Actively Recruiting
6
The George Washington Medical facility Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
7
City of Hope Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
8
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
10
St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, United States, 59102
Actively Recruiting
11
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
12
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
13
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
14
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
16
Hopital de l'Institut Curie
Paris, France, 75005
Actively Recruiting
17
Hopital Europeen Georges Pompidou (HEGP)
Paris, France, 75015
Actively Recruiting
18
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France, 86000
Actively Recruiting
19
Azienda Ospedaliero Universitaria delle Marche
Torrette, AN, Italy, 60126
Actively Recruiting
20
Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia
Novara, Italy, 28100
Actively Recruiting
21
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
22
Inha University Hospital
Incheon, South Korea, 22332
Actively Recruiting
23
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
24
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
25
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
26
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
27
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
28
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain, 29010
Actively Recruiting
29
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
30
Hospital Universitari Arnau de Villanova
Lleida, Catalonia, Spain, 25198
Actively Recruiting
31
Barts Health NHS Trust - St Bartholomew's Hospital
London, Greater London, United Kingdom, EC1A 7BE
Actively Recruiting
32
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, Wales, United Kingdom, CF14 2TL
Actively Recruiting
Research Team
C
Cheng Quah, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here