Recruiting
Phase 2

Evorpacept & Anti-Cancer Therapies

Sponsor:

ALX Oncology Inc.

Code:

NCT07007559

Conditions

Breast Cancer, Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Evorpacept (ALX148)

Trastuzumab

Paclitaxel

Capecitabine

Eribulin

Study Details

Brief 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.

Conditions

Breast Cancer, Metastatic

Study ID

NCT07007559

Start date

Dec 10, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer

  • Evorpacept (IV) - once every 3 weeks (Q3W)
  • Trastuzumab (IV) - once every 3 weeks (Q3W)
  • Chemotherapy (physician selects one of the following):

  • Capecitabine (Oral) twice a day for 14 days every 3 weeks
  • Eribulin (IV) twice every 3 weeks
  • Gemcitabine (IV) twice every 3 weeks
  • Paclitaxel (IV) once every 3 weeks (Q3W) or once weekly (QW)
  • Vinolrebine (IV) twice every 3 weeks

Interventions

Evorpacept (ALX148)

IV infusion

Trastuzumab

IV infusion

Paclitaxel

IV infusion

Capecitabine

Oral administration

Eribulin

IV infusion

Gemcitabine

IV infusion

Vinorelbine

IV infusion

Primary outcome measure

  • Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment [ Time Frame: Approximately 6 months after the last participant is enrolled ]

Central Contacts and Locations

Central contacts

Cheng Quah, MD

650-466-7125info@alxoncology.com

Locations

The University of Arizona Cancer Center - North Campus

Recruiting

Tucson, Arizona, United States, 85719

City of Hope

Recruiting

Duarte, California, United States, 91010

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

UC Irvine Health - Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 928686

Saint Joseph Hospital - Cancer Centers of Colorado

Recruiting

Denver, Colorado, United States, 80218

Lutheran Hospital - Cancer Centers of Colorado

Recruiting

Golden, Colorado, United States, 80401

Saint Mary's Regional Hospital - Cancer Centers of Colorado

Recruiting

Grand Junction, Colorado, United States, 81501

The George Washington Medical facility Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

City of Hope Chicago

Recruiting

Zion, Illinois, United States, 60099

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

HealthPartners Frauenshuh Cancer Center

Recruiting

Saint Louis Park, Minnesota, United States, 55426

Washington University School of Medicine- Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

St. Vincent Regional Hospital - Cancer Centers of Montana

Recruiting

Billings, Montana, United States, 59102

Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Study Coordinator

402-334-4773

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10022

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Houston Methodist Cancer Center

Recruiting

Houston, Texas, United States, 77030

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

University Health Network, Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

ALX Oncology Inc.

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • metastatic
  • Her2+
  • metastatic HER2-positive breast cancer
  • breast cancer
  • HER2-positive
  • Evorpacept
  • CD47
  • ERBB2
  • Enhertu
  • trastuzumab deruxtecan
  • ASPEN-09
  • Herceptin
  • solid tumors
  • trastuzumab
  • ALX148
  • mBC
  • ASPEN-Breast

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ALX Oncology Inc. on 2026-08-14.