Actively Recruiting
A Phase 2 Single-Arm Study of Evorpacept Combined With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer Under Master Protocol ASPEN-09
Led by ALX Oncology Inc. · Updated on 2026-06-05
120
Participants Needed
44
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of evorpacept with trastuzumab and chemotherapy in adults with HER2-positive metastatic breast cancer who have previously been treated with trastuzumab-deruxtecan. This Phase 2, single-arm, multicenter study aims to assess the treatment's effectiveness, safety, and tolerability. It is part of a larger master protocol studying evorpacept with various anti-cancer therapies in advanced malignancies. Participants will receive evorpacept and trastuzumab intravenously every three weeks, along with one of several chemotherapy options chosen by their doctor. Chemotherapy options include oral capecitabine twice daily for 14 days every three weeks or intravenous eribulin, gemcitabine, paclitaxel, or vinorelbine with varying schedules. Treatment continues until disease progression, unacceptable side effects, participant choice, investigator decision, or study end. During the study, participants will have assessments of tumor response using standard criteria approximately six months after enrollment ends. Researchers will monitor overall response rate, clinical benefit rate, duration of response, progression-free survival, overall survival, and side effects. Blood samples will be collected to study drug levels and immune response. Participants are followed until 28 days after the last treatment dose, with safety and efficacy carefully tracked throughout the study period.
CONDITIONS
Brief 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...
- Adults with invasive HER2-positive breast cancer confirmed by tissue analysis
- Previously treated with at least one therapy line including trastuzumab-deruxtecan for advanced or metastatic disease
- Disease that has progressed after the most recent treatment
- Eligible to receive one of the listed chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel, or vinorelbine)
- Measurable tumor disease by RECIST v1.1 criteria
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Adequate kidney function with creatinine clearance of 30 mL/min or higher
- Adequate liver function within specified limits
- Recovered from prior treatment side effects to baseline or mild levels except for non-safety-related effects
You will not qualify if you...
- Known central nervous system metastases unless treated and stable before enrollment
- Prior treatment with anti-CD47 or anti-SIRPα agents
- Conditions preventing safe use of trastuzumab
- Complete deficiency of dihydropyrimidine dehydrogenase (DPD) or severe toxicity to fluorouracil-based treatments
- Recent anti-cancer treatments without required washout periods
- History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction
- Previous allogeneic tissue or organ transplant
- Active or unstable heart disease
- Severe allergic reactions to antibodies or study drug components
- Active autoimmune disease requiring systemic treatment within past 2 years
- Another primary cancer diagnosed within past 2 years
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Until disease progression or discontinuation
Participants receive Evorpacept and Trastuzumab infusions every 3 weeks combined with one of several chemotherapy options selected by their physician. Treatment continues until disease progression, unacceptable toxicity, participant decision to stop, investigator decision, or study termination.
Infusions once every 3 weeks and oral chemotherapy twice daily for 14 days every 3 weeks depending on regimen; paclitaxel may be given weekly or every 3 weeks
Trial Site Locations
Total: 44 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
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
4
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States, 928686
Actively Recruiting
5
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States, 80218
Actively Recruiting
6
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, United States, 80401
Actively Recruiting
7
Saint Mary's Regional Hospital - Cancer Centers of Colorado
Grand Junction, Colorado, United States, 81501
Actively Recruiting
8
The George Washington Medical facility Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
9
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
10
City of Hope Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
11
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
13
St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, United States, 59102
Actively Recruiting
14
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
15
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
Actively Recruiting
16
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
17
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
18
Houston Methodist Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
19
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
20
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
21
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
22
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
23
Hopital de l'Institut Curie
Paris, France, 75005
Actively Recruiting
24
Hopital Europeen Georges Pompidou (HEGP)
Paris, France, 75015
Actively Recruiting
25
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France, 86000
Actively Recruiting
26
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
27
Azienda Ospedaliero Universitaria delle Marche
Torrette, AN, Italy, 60126
Actively Recruiting
28
IRCCS Azienda Ospedaliera Metropolitana
Genova, GE, Italy, 16132
Actively Recruiting
29
Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia
Novara, Italy, 28100
Actively Recruiting
30
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
31
Curie Oncology - Farrer
Singapore, Singapore, 217562
Actively Recruiting
32
Inha University Hospital
Incheon, South Korea, 22332
Actively Recruiting
33
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
34
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
35
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
36
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
37
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
38
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain, 29010
Actively Recruiting
39
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
40
Hospital Universitari Arnau de Villanova
Lleida, Catalonia, Spain, 25198
Actively Recruiting
41
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
42
Hospital Beata Maria Ana
Madrid, Spain, 28007
Actively Recruiting
43
Barts Health NHS Trust - St Bartholomew's Hospital
London, Greater London, United Kingdom, EC1A 7BE
Actively Recruiting
44
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, Wales, United Kingdom, CF14 2TL
Actively Recruiting
Research Team
C
Cheng Quah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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