OncoMatch/Clinical Trials/NCT07007559
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Is NCT07007559 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments for breast cancer, metastatic.
Treatment: Evorpacept (ALX148) · Trastuzumab · Paclitaxel · Capecitabine · Eribulin · Gemcitabine · Vinorelbine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
HER2+ breast cancer based on an evaluable tumor tissue biopsy
Disease stage
Required: Stage IV
Metastatic disease required
Measurable disease as defined by RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab deruxtecan) — locally advanced/metastatic HER2+ breast cancer
including at least one prior line of T-DXd (ENHERTU) for locally advanced/metastatic HER2+ breast cancer
Cannot have received: anti-CD47 therapy
Prior exposure to any anti-CD47 or anti-SIRPα agent
Lab requirements
Kidney function
estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation or CKD-EPI equation
Liver function
Total bilirubin ≤1.5 x ULN (≤3.0 x ULN if the participant has documented Gilbert syndrome); AST and ALT ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease)
Cardiac function
LVEF ≥50%
LVEF ≥50%. Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation or CKD-EPI equation). Adequate liver function: Total bilirubin ≤1.5 x ULN (≤3.0 x ULN if the participant has documented Gilbert syndrome); AST and ALT ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Arizona Cancer Center - North Campus · Tucson, Arizona
- City of Hope · Duarte, California
- UC San Diego Moores Cancer Center · La Jolla, California
- UC Irvine Health - Chao Family Comprehensive Cancer Center · Orange, California
- Saint Joseph Hospital - Cancer Centers of Colorado · Denver, Colorado
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07007559 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CD47 therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages