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Clinical Trials in the UK / NCT07007559
Recruiting Phase 2

ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer

NCT07007559 · tracked via the Priya Life Science UK tracker
Sponsor
ALX Oncology Inc.
Phase
Phase 2
Started
2025-12-10
Last updated
2026-08-14

Condition(s) studied

Breast Cancer, Metastatic

Investigational drug(s) / intervention(s)

Evorpacept (ALX148)TrastuzumabPaclitaxelCapecitabineEribulinGemcitabineVinorelbine

Evorpacept (ALX148): IV infusion

Trastuzumab: IV infusion

Paclitaxel: IV infusion

Capecitabine: Oral administration

Eribulin: IV infusion

Gemcitabine: IV infusion

Vinorelbine: IV infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed invasive HER2+ breast cancer based on an evaluable tumor tissue biopsy obtained after cessation of T-DXd (ENHERTU) treatment and no more than 6 months prior to C1D1. * Received no more than 4 prior lines of HER2-directed therapy including at least one prior line of 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. Exclusion Criteria: * Untreated CNS metastases. * 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: 1. 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. 2. 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.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
The University of Arizona Cancer Center - North Campus Tucson Arizona Recruiting
City of Hope Duarte California Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center Orange California Recruiting
Saint Joseph Hospital - Cancer Centers of Colorado Denver Colorado Recruiting
Lutheran Hospital - Cancer Centers of Colorado Golden Colorado Recruiting
Saint Mary's Regional Hospital - Cancer Centers of Colorado Grand Junction Colorado Recruiting
The George Washington Medical facility Associates Washington D.C. District of Columbia Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Recruiting
City of Hope Chicago Zion Illinois Recruiting
University of Michigan Rogel Cancer Center Ann Arbor Michigan Recruiting
HealthPartners Frauenshuh Cancer Center Saint Louis Park Minnesota Recruiting
Washington University School of Medicine- Siteman Cancer Center St Louis Missouri Recruiting
St. Vincent Regional Hospital - Cancer Centers of Montana Billings Montana Recruiting
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists Omaha Nebraska Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Gabrail Cancer Center Canton Ohio Recruiting
Oregon Health and Science University Portland Oregon Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Houston Methodist Cancer Center Houston Texas Recruiting
The University of Texas M.D. Anderson Cancer Center Houston Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
University Health Network, Princess Margaret Cancer Centre Toronto Ontario Recruiting
CHU de Besancon Besançon France Recruiting
Hopital de l'Institut Curie Paris France Recruiting
Hopital Europeen Georges Pompidou (HEGP) Paris France Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers Poitiers France Recruiting
Centre Eugene Marquis Rennes France Recruiting
Azienda Ospedaliero Universitaria delle Marche Torrette AN Recruiting
IRCCS Azienda Ospedaliera Metropolitana Genova GE Recruiting
ASST Papa Giovanni XXIII Bergamo Italy Recruiting
IRCCS Azienda Ospedaliero- Universitaria di Bologna, Policlinico di Sant'Orsola Bologna Italy Recruiting
IRCCS- Istituto Europeo di Oncologia Milan Italy Recruiting
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy Recruiting
Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia Novara Italy Recruiting
National Cancer Centre Singapore Singapore Singapore Recruiting
Curie Oncology - Farrer Singapore Singapore Recruiting
Inha University Hospital Incheon South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting

+ 14 more sites — see the full list on the official registry below.

On this site

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More ALX Oncology Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07007559 on ClinicalTrials.gov ↗ ← All trials in the UK