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RECRUITING Phase 1

ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

NCT07007559 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies: * Metastatic HER2+ breast cancer (MBC) - single-arm substudy 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. * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.

Conditions Studied

Interventions

  • DRUG Trastuzumab
  • DRUG Capecitabine
  • DRUG Paclitaxel
  • DRUG Evorpacept (ALX148)
  • DRUG Eribulin

Study Locations (11)

Colorado

  • Saint Joseph Hospital - Cancer Centers of Colorado — Denver
  • Lutheran Hospital - Cancer Centers of Colorado — Golden
  • Saint Mary's Regional Hospital - Cancer Centers of Colorado — Grand Junction

Texas

  • University of Texas Southwestern Medical Center — Dallas
  • The University of Texas M.D. Anderson Cancer Center — Houston

Arizona

  • The University of Arizona Cancer Center - North Campus — Tucson

District of Columbia

  • The George Washington Medical facility Associates — Washington D.C.

Michigan

  • University of Michigan Rogel Cancer Center — Ann Arbor

Minnesota

  • HealthPartners Frauenshuh Cancer Center — Saint Louis Park

Nebraska

  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists — Omaha

Ohio

  • Gabrail Cancer Center — Canton

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2025-04-28
Est. Completion 2027-12
Phase Phase 1

Sponsor

ALX Oncology

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07007559

The ClinicalTrials.gov registry entry for NCT07007559 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ALX Oncology, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer, Metastatic appearing as the primary indexed condition, and to 5 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07007559 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Colorado, Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07007559 about?

NCT07007559 is a clinical study titled "ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies". The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies: * Metastatic HER2+ breast cancer (MBC) - single-arm substudy evaluating the efficacy, safety, and tolerability of evorpacept in com...

What is the current status of trial NCT07007559?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2025-04-28. Estimated completion is 2027-12.

What conditions does trial NCT07007559 study?

This clinical trial studies the following conditions: Breast Cancer, Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07007559?

The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG), Evorpacept (ALX148) (DRUG), Eribulin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07007559?

This trial is sponsored by ALX Oncology, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07007559 being conducted?

This trial has 11 study locations across Arizona, Colorado, District of Columbia, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial