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NCT03255070 · ClinicalTrials.gov registry record · Phase 1
A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)
A Phase 1 study of Solid Tumors and Breast Neoplasms, sponsored by Ambrx.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 12
- Study locations
NCT03255070: Completed Phase 1 study of Solid Tumors and Breast Neoplasms, sponsored by Ambrx.
NCT03255070 is a Phase 1 study of Solid Tumors and Breast Neoplasms that has completed, run by Ambrx. The registered enrollment target is 106 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (63% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03255070, a Phase 1 study of Solid Tumors and Breast Neoplasms, has completed, sponsored by Ambrx.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 12
- Study locations
Study Summary
This 2-part, Phase 1, open-label study will determine the recommended Phase 2 dose (RP2D) of ARX788 in subjects with advanced HER2 positive cancers and will assess the safety and anticancer activity in breast, gastric and other advanced HER2 positive solid tumors.
Primary Outcome
To assess the safety, tolerability, and immunogenicity profile
Conditions Studied
Interventions
- DRUG ARX788
Study Locations (12)
California
- USC Norris Cancer Hospital - Los Angeles
- UCLA Hematology-Oncology - Santa Monica
New South Wales
- Research Site - East Albury
- Research Site - North Sydney
Queensland
- Mater Misericordiae Limited - South Brisbane
- Princess Alexandria Hospital - Woolloongabba
Victoria
- Monash Health - Clayton
- Research Site - Frankston
Missouri
- Washington University School of Medicine - St Louis
Ohio
- Cleveland Clinic - Cleveland
Texas
- Baylor Sammons Cancer Center - Dallas
Western Australia
- Research Site - Nedlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2023-10-18 |
| Phase | Phase 1 |
What the finished NCT03255070 record still lists
NCT03255070 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (63% lower).
The record links to 3 conditions, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which ARX788 is the first listed.
NCT03255070 lists 12 locations in 8 states (California, New South Wales, Queensland).
Frequently Asked Questions
What is clinical trial NCT03255070 about?
NCT03255070 is a clinical study titled "A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)". This 2-part, Phase 1, open-label study will determine the recommended Phase 2 dose (RP2D) of ARX788 in subjects with advanced HER2 positive cancers and will assess the safety and anticancer activity in breast, gastric and other advanced HER2 positive solid tumors.
What is the current status of trial NCT03255070?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2018-03-20. Estimated completion is 2023-10-18.
What conditions does trial NCT03255070 study?
This clinical trial studies the following conditions: Solid Tumors, Breast Neoplasms, Gastric Neoplasm.
What interventions are being tested in trial NCT03255070?
The interventions under investigation include: ARX788 (DRUG).
Who is sponsoring clinical trial NCT03255070?
This trial is sponsored by Ambrx, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03255070 being conducted?
This trial has 12 study locations across California, Missouri, Ohio, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
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 NCT03255070's enrollment target sits among peer trials
106 50th of 125 higher than 76 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors 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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