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RECRUITING
NCT07007559
PHASE2

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

Sponsor: ALX Oncology Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-12-10

Completion Date

2028-12

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Evorpacept (ALX148)

IV infusion

DRUG

Trastuzumab

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Capecitabine

Oral administration

DRUG

Eribulin

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Vinorelbine

IV infusion

Locations (28)

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 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

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