Clinical Trial

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

Study acronym: ASPEN-09-03
Recruiting Phase 2
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.
Protocol Amendment History 9 changes
notable Trial sites expanded: 44 -> 54 locations 2026-08-15
notable Trial sites expanded: 32 -> 44 locations 2026-06-06
notable Trial sites expanded: 28 -> 32 locations 2026-04-14
critical Phase changed: Phase 1/2 -> Phase 2 2026-04-08
critical Primary endpoint(s) modified 2026-04-08
notable Enrollment increased: 80 -> 120 participants 2026-04-08
notable Trial sites expanded: 11 -> 28 locations 2026-04-08
notable Primary completion pushed: 2027-06 -> 2027-12 2026-04-08
minor Completion pushed: 2027-12 -> 2028-12 2026-04-08
Trial Details
NCT Number NCT07007559
Lead Sponsor ALX Oncology Inc.
Conditions Breast Cancer, Metastatic
Enrollment 120 participants
Start Date 2025-12-10
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-14