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COMPLETED Phase 1

A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)

NCT03255070 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 106 participants
Start Date 2018-03-20
Est. Completion 2023-10-18
Phase Phase 1

Sponsor

Ambrx

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03255070

The ClinicalTrials.gov registry entry for NCT03255070 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ambrx, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03255070 reports 12 study locations spanning 8 distinct geographic areas — top geographies include California, New South Wales, Queensland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03255070?

The interventions under investigation include: ARX788 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03255070?

This trial is sponsored by Ambrx, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial