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NCT06224673 · ClinicalTrials.gov registry record · Phase 2
ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer
A Phase 2 study, sponsored by Laura Huppert, MD, BA.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT06224673: Recruiting Phase 2 study, sponsored by Laura Huppert, MD, BA.
NCT06224673 is a Phase 2 study that is actively recruiting participants, run by Laura Huppert, MD, BA. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06224673, a Phase 2 study, is actively recruiting participants, sponsored by Laura Huppert, MD, BA.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer. ARX788 is an antibody-drug conjugate (ADC) that is given by infusion (diluted and injected slowly into veins). Antibodies are proteins which are naturally produced by the body's immune system to help fight infections. ARX788 consists of antibodies that have been attached to a toxin that has the potential to kill cancer cells. ARX788 sticks to a protein called human epidermal growth factor receptor (HER2), which is found on some breast cancer cells. Giving ARX788 may be safe and effective in treating patients with HER2-low locally advanced unresectable metastatic breast cancer.
Primary Outcome
Objective response rate (ORR) is defined as the proportion of participants who experience complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The ORR and corresponding two-sided exact 90% confidence intervals will be reported.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography (CT)
- DRUG Amiloride
- DRUG ARX788
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-06-05 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 2 |
What NCT06224673 shows while recruiting
NCT06224673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT06224673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06224673 about?
NCT06224673 is a clinical study titled "ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer". This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer. ARX788 is an antibody-drug conjugate (ADC) that is given by infusion (diluted and injected slowly into veins). Antibodies are proteins which are na...
What is the current status of trial NCT06224673?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2026-06-05. Estimated completion is 2029-11-30.
What interventions are being tested in trial NCT06224673?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (CT) (PROCEDURE), Amiloride (DRUG), ARX788 (DRUG).
Who is sponsoring clinical trial NCT06224673?
This trial is sponsored by Laura Huppert, MD, BA, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06224673's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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