Phase 2 Breast Cancer Trial, Recruiting NCT07007559 Sponsor: ALX Oncology Inc. Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT07007559
Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with invasive HER2-positive breast cancer, confirmed by a tissue sample test.
  • People who have received at least one previous treatment for advanced or metastatic HER2-positive breast cancer that included the drug T-DXd (also known as ENHERTU), or whose cancer came back within 6 months of finishing T-DXd as a pre-surgery treatment. People who stopped T-DXd because they could not tolerate it are also considered eligible.
  • People whose cancer has continued to grow or spread during or after their most recent treatment.
  • People whose doctors determine are suitable to receive one of the following chemotherapy medicines: capecitabine, eribulin, gemcitabine, paclitaxel, or vinorelbine.
  • People who have measurable disease that can be tracked on scans, as defined by standard measurement guidelines (RECIST v1.1).
  • People whose heart pumping function (LVEF) is at least 50%.
  • People with a general health and activity level rated as 0 or 1 on a standard medical scale (ECOG), meaning they are fully active or have minor limitations but are able to carry out light activity.
  • People with a life expectancy of at least 3 months.
  • People with adequate kidney function, based on a standard calculation of how well the kidneys filter waste.
  • People with adequate liver function, based on standard blood test results for liver enzymes and bilirubin (with slightly different thresholds allowed for people with a specific liver condition called Gilbert syndrome, or those with cancer that has spread to the liver).
  • People who have recovered from side effects of previous cancer treatments, with any remaining side effects being mild or at a stable baseline level (confirm with trial site).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People with cancer that has spread to the brain or central nervous system, unless that spread has been treated and is stable before joining the trial.
  • People who have previously received any treatment targeting CD47 or SIRPα (certain types of immune-based therapies).
  • People for whom receiving the drug trastuzumab would be medically inadvisable.
  • People who have a complete deficiency of an enzyme called DPD, or who have had serious side effects from a previous treatment containing 5-fluorouracil (5FU).
  • People who have recently received certain cancer treatments and have not waited long enough before starting this trial — including chemotherapy, hormone therapy, radiation, or targeted small-molecule drugs (within 14 days or 5 half-lives, whichever is shorter), or immune therapies and antibody-based treatments (within 28 days or 5 half-lives, whichever is shorter).
  • People with a history of certain immune-related blood conditions, specifically autoimmune hemolytic anaemia, autoimmune thrombocytopenia, or a serious reaction to a blood transfusion.
  • People who have had an organ or tissue transplant from another person.
  • People with active or unstable heart or cardiovascular disease.
  • People who have had a severe allergic or anaphylactic reaction to antibody-based medicines, infused therapeutic proteins, or any ingredient in the study drugs.
  • People with an active autoimmune disease that has required systemic (whole-body) medical treatment within the past 2 years.
  • People who have been diagnosed with another separate cancer within the past 2 years.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

Contact this trial

Phone: 650-466-7125

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
ALX Oncology Inc.
Registry
ClinicalTrials.gov
Start date
10 December 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇨🇦 Canada 🇫🇷 France 🇮🇹 Italy 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov