ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Public ClinicalTrials.gov record NCT07007559. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07007559
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
- Evorpacept (ALX148) Drug
- Trastuzumab Drug
- Paclitaxel Drug
- Capecitabine Drug
- Eribulin Drug
- Gemcitabine Drug
- Vinorelbine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 9, 2025
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2028
- Last update posted
- Aug 13, 2026
2025 – 2028
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | 85719 | Recruiting |
| City of Hope | Duarte | California | 91010 | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | 92037 | Recruiting |
| UC Irvine Health - Chao Family Comprehensive Cancer Center | Orange | California | 928686 | Recruiting |
| Saint Joseph Hospital - Cancer Centers of Colorado | Denver | Colorado | 80218 | Recruiting |
| Lutheran Hospital - Cancer Centers of Colorado | Golden | Colorado | 80401 | Recruiting |
| Saint Mary's Regional Hospital - Cancer Centers of Colorado | Grand Junction | Colorado | 81501 | Recruiting |
| The George Washington Medical facility Associates | Washington D.C. | District of Columbia | 20037 | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | Recruiting |
| City of Hope Chicago | Zion | Illinois | 60099 | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | Recruiting |
| HealthPartners Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | Recruiting |
| Washington University School of Medicine- Siteman Cancer Center | St Louis | Missouri | 63108 | Recruiting |
| St. Vincent Regional Hospital - Cancer Centers of Montana | Billings | Montana | 59102 | Recruiting |
| Oncology Hematology West, Pc Dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10022 | Recruiting |
| Gabrail Cancer Center | Canton | Ohio | 44718 | Recruiting |
| Oregon Health and Science University | Portland | Oregon | 97239 | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | Recruiting |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07007559, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07007559 live on ClinicalTrials.gov.