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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 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.

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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.

Conditions Studied

Solid Tumors Breast Neoplasms Gastric Neoplasm

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, categorized as Phase 1. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (63% lower). The listed sponsor is Ambrx, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.