Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07007559

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.

Not Eligible

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:

    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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

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