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NCT04829604 · ClinicalTrials.gov registry record · Phase 2
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
A Phase 2 study of HER2-positive Metastatic Breast Cancer, sponsored by Ambrx.
- Active
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT04829604: Active Phase 2 study of HER2-positive Metastatic Breast Cancer, sponsored by Ambrx.
NCT04829604 is a Phase 2 study of HER2-positive Metastatic Breast Cancer that is active but no longer recruiting, run by Ambrx. The registered enrollment target is 72 participants, below the 118-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04829604, a Phase 2 study of HER2-positive Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Ambrx.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
Primary Outcome
To evaluate the confirmed objective response rate (ORR) as determined by Investigator assessment based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) following treatment with ARX788. The ORR is defined as the number of subjects with a BOR of CR or PR divided by the number of response evaluable subjects.
Conditions Studied
Interventions
- DRUG ARX788
Study Locations (20)
California
- Research Site - Los Angeles
- Research Site - Newport Beach
- Research Site - San Francisco
- Research Site - Whittier
New York
- Research Site - New Hyde Park
- Research Site - New York
- Research Site - Shirley
- Research Site - The Bronx
Oregon
- Research Site - Portland
- Research Site - Tigard
Georgia
- Research Site - Atlanta
Illinois
- Research Site - Chicago
Kentucky
- Research Site - Louisville
Maryland
- Research Site - Silver Spring
Massachusetts
- Research Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What the registry record for NCT04829604 still lists
NCT04829604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 118-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (39% lower).
The record links to 1 condition, with HER2-positive Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which ARX788 is the first listed.
NCT04829604 names 20 study sites across 13 states, led by California, New York, Oregon.
Frequently Asked Questions
What is clinical trial NCT04829604 about?
NCT04829604 is a clinical study titled "ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)". A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
What is the current status of trial NCT04829604?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2021-10-26. Estimated completion is 2027-06.
What conditions does trial NCT04829604 study?
This clinical trial studies the following conditions: HER2-positive Metastatic Breast Cancer.
What interventions are being tested in trial NCT04829604?
The interventions under investigation include: ARX788 (DRUG).
Who is sponsoring clinical trial NCT04829604?
This trial is sponsored by Ambrx, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04829604 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04829604's enrollment target sits among peer trials
72 7th of 11 higher than 5 of 11 other HER2-positive Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Metastatic Breast Cancer 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.
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