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NCT07007559 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer Metastatic, sponsored by ALX Oncology.

Recruiting
Registry status
Phase 1
Development phase
80
Enrollment target
11
Study locations

NCT07007559: Recruiting Phase 1 study of Breast Cancer Metastatic, sponsored by ALX Oncology.

NCT07007559 is a Phase 1 study of Breast Cancer Metastatic that is actively recruiting participants, run by ALX Oncology. The registered enrollment target is 80 participants, roughly in line with the 88-participant average among 17 other Breast Cancer Metastatic trials with a reported enrollment target. The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07007559, a Phase 1 study of Breast Cancer Metastatic, is actively recruiting participants, sponsored by ALX Oncology.

RECRUITING
Registry status
Phase 1
Development phase
80 participants
Enrollment target
11
Study locations

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.

Primary Outcome

Evaluate the ORR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). ORR is defined as a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST v1.1 based on BICR assessment.

Conditions Studied

Breast Cancer Metastatic

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
ALX Oncology

9 total trials

What NCT07007559 shows while recruiting

NCT07007559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, roughly in line with the 88-participant average among 17 other Breast Cancer Metastatic trials with a reported enrollment target.

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.

NCT07007559 lists 11 locations in 8 states (Colorado, Texas, Arizona).

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.

What interventions are being tested in trial NCT07007559?

The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG), Evorpacept (ALX148) (DRUG), Eribulin (DRUG).

Who is sponsoring clinical trial NCT07007559?

This trial is sponsored by ALX Oncology, which has 9 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Breast Cancer Metastatic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07007559's enrollment target sits among peer trials

80 6th of 17 higher than 12 of 17 other Breast Cancer Metastatic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer Metastatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07007559

Source: ClinicalTrials.gov NCT07007559, the US trial registry maintained by the National Library of Medicine. NCT07007559 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.