OncoMatch/Clinical Trials/NCT07007559
ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
Is NCT07007559 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for breast cancer, metastatic.
Treatment: Evorpacept (ALX148) · Trastuzumab · Paclitaxel · Capecitabine · Eribulin · Gemcitabine · Vinorelbine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
HER2 positive breast cancer
Excluded: DPYD complete deficiency
Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab deruxtecan) — locally advanced/metastatic
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
Cannot have received: anti-CD47 or anti-SIRPα agent
Prior exposure to any anti-CD47 or anti-SIRPα agent
Cannot have received: flurouracil (5FU) based regimen
Exception: significant toxicity
significant toxicity with prior flurouracil (5FU) based regimen
Lab requirements
Kidney function
estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation
Liver function
Total bilirubin ≤1.5 x ULN (≤3.0 x ULN if Gilbert syndrome); AST and ALT ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease)
Cardiac function
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 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). LVEF ≥50%
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
- Saint Joseph Hospital - Cancer Centers of Colorado · Denver, Colorado
- Lutheran Hospital - Cancer Centers of Colorado · Golden, Colorado
- Saint Mary's Regional Hospital - Cancer Centers of Colorado · Grand Junction, Colorado
- The George Washington Medical facility Associates · Washington D.C., District of Columbia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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