RecruitingPhase 2NCT07007559

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

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

Sponsor

ALX Oncology Inc.

Enrollment

120 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (ASPEN-09) is testing an experimental drug called evorpacept in combination with other cancer therapies for people with advanced or metastatic solid tumors, including a specific group for HER2-positive metastatic breast cancer. Evorpacept works by blocking a signal that cancer cells use to hide from the immune system. **You may be eligible if...** - You are 18 years or older - You have at least one measurable tumor and are in good overall health (ECOG 0–1) - For the breast cancer group: you have HER2-positive metastatic breast cancer that progressed after receiving T-DXd (trastuzumab deruxtecan) and at least one other treatment - You are eligible to receive one of the study's chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel, or vinorelbine) - Your heart, kidney, and liver function meet required levels **You may NOT be eligible if...** - Your cancer has not received prior T-DXd therapy (for the breast cancer group) - You have poor overall health or recent unresolved side effects from prior treatments - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEvorpacept (ALX148)

IV infusion

DRUGTrastuzumab

IV infusion

DRUGPaclitaxel

IV infusion

DRUGCapecitabine

Oral administration

DRUGEribulin

IV infusion

DRUGGemcitabine

IV infusion

DRUGVinorelbine

IV infusion

Locations(32)

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Lutheran Hospital - Cancer Centers of Colorado

Golden, Colorado, United States

Saint Mary's Regional Hospital - Cancer Centers of Colorado

Grand Junction, Colorado, United States

The George Washington Medical facility Associates

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

City of Hope Chicago

Zion, Illinois, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States

St. Vincent Regional Hospital - Cancer Centers of Montana

Billings, Montana, United States

Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Gabrail Cancer Center

Canton, Ohio, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Hopital de l'Institut Curie

Paris, France

Hopital Europeen Georges Pompidou (HEGP)

Paris, France

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, France

Azienda Ospedaliero Universitaria delle Marche

Torrette, AN, Italy

Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia

Novara, Italy

National Cancer Centre Singapore

Singapore, Singapore

Inha University Hospital

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital Universitario Virgen Macarena

Seville, Andalusia, Spain

Hospital Universitari Arnau de Villanova

Lleida, Catalonia, Spain

Barts Health NHS Trust - St Bartholomew's Hospital

London, Greater London, United Kingdom

Velindre Cancer Centre, Velindre University NHS Trust

Cardiff, Wales, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07007559

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