RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

Quick Facts

Study Start:2025-04-28
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07007559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Cheng Quah, MD
CONTACT
650-466-7125
info@alxoncology.com
Alan Sandler, MD
CONTACT
650-466-7125
info@alxoncology.com

Study Locations (Sites)

Gabrail Cancer Center
Canton, Ohio, 44718
United States

Collaborators and Investigators

Sponsor: ALX Oncology Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-28
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-04-28
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Breast Cancer, Metastatic