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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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 →Frequently asked questions
Is NCT07007559 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CD47 or anti-SIRPα agent, flurouracil (5FU) based regimen disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Are patients with DPYD alterations eligible?
No. DPYD complete deficiency is an exclusion criterion.
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