Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Evorpacept (ALX148) for Breast Cancer, Metastatic

The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the how well it works, 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. 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.

Official registry: https://clinicaltrials.gov/study/NCT07007559 · ALX Oncology Inc. · enrollment listed as 120

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Evorpacept (ALX148), Trastuzumab, or Paclitaxel. The registry lists allocation as na. The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the how well it works, 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.

They plan to enroll about 120 people at 61 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

Interventions: Evorpacept (ALX148), Trastuzumab, Paclitaxel, Capecitabine, Eribulin, Gemcitabine, Vinorelbine

Primary outcome (registry wording): Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Histologically confirmed invasive HER2+ breast cancer based on an evaluable tumor tissue biopsy obtained after cessation of T-DXd (ENHERTU) treatment and no more than 6 months prior to C1D1
  • 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)
  • Measurable disease 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
  • Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

Public study contact (from the registry)

Cheng Quah, MD

650-466-7125

info@alxoncology.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

61 listed

+ 33 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07007559 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07007559?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07007559?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary