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

NCT ID: NCT07007559

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, investigator decision or study termination by the sponsor.

Not all substudies may be active and/or open to enrollment at a given time. Not all study centers may be participating in every substudy. MBC substudy will be the first to enroll - thus the information reflected in the enrollment number, arms/interventions, outcome measures, and eligibility criteria only include MBC at this time.

Conditions

Breast Cancer, Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer

• Evorpacept (IV) - once every 3 weeks (Q3W)
• Trastuzumab (IV) - once every 3 weeks (Q3W)
• Chemotherapy (physician selects one of the following):

• Capecitabine (Oral) 14 days every 3 weeks
• Eribulin (IV) twice every 3 weeks
• Gemcitabine (IV) twice every 3 weeks
• Paclitaxel (IV) once every 3 weeks (Q3W)
• Vinolrebine (IV) twice every 3 weeks

Group Type: EXPERIMENTAL

Evorpacept (ALX148)

Intervention Type: DRUG

IV infusion

Trastuzumab

Intervention Type: DRUG

IV infusion

Paclitaxel

Intervention Type: DRUG

IV infusion

Capecitabine

Intervention Type: DRUG

Oral administration

Eribulin

Intervention Type: DRUG

IV infusion

Gemcitabine

Intervention Type: DRUG

IV infusion

Vinorelbine

Intervention Type: DRUG

IV infusion

Interventions

Evorpacept (ALX148)

IV infusion

Intervention Type: DRUG

Trastuzumab

IV infusion

Intervention Type: DRUG

Paclitaxel

IV infusion

Intervention Type: DRUG

Capecitabine

Oral administration

Intervention Type: DRUG

Eribulin

IV infusion

Intervention Type: DRUG

Gemcitabine

IV infusion

Intervention Type: DRUG

Vinorelbine

IV infusion

Intervention Type: DRUG

Other Intervention Names

Herceptin; Taxol; Xeloda; Halaven; Gemzar; Navelbine

Eligibility Criteria

Inclusion Criteria

• Participants must have at least one measurable lesion as defined by RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.
• Life expectancy of at least 3 months
• Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible which do not constitute a safety risk by Investigator judgment

MBC substudy:

• Histologically confirmed invasive HER2 positive breast cancer
• Available tumor tissue (FFPE slides or block). A fresh biopsy is preferred but optional.
• Received at least one prior line of therapy including T-DXd for locally advanced/metastatic HER2 positive breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease.
• Progressed on or following the most recent line of therapy
• Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine)
• LVEF ≥50%
• Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation
• Adequate liver function:
• Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome);
• Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).

Exclusion Criteria

• Participants with known CNS metastases unless treated and stable prior to enrollment
• Following anti-cancer therapy with insufficient washout before C1D1:

1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of C1D1.

2. Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of C1D1)

• Prior exposure to any anti-CD47 or anti-SIRPα agent.
• History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.
• Had an allogeneic tissue/solid organ transplant.
• Any active, unstable cardiovascular disease
• Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).
• Has an active autoimmune disease that has required systemic treatment in past 2 years

MBC substudy:

• Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen
• Other primary malignancy within 2 years
• Any condition that would be contraindicated to receiving trastuzumab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALX Oncology Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States

Site Status: RECRUITING

Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Site Status: RECRUITING

Gabrail Cancer Center

Canton, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cheng Quah, MD

Role: CONTACT

info@alxoncology.com

650-466-7125

Facility Contacts

Study Coordinator

Role: primary

Study Coordinator

Role: primary

402-334-4773

Study Coordinator

Role: primary

Other Identifiers

AT148009

Identifier Type: -

Identifier Source: org_study_id