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ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer

NCT06224673 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-05-01

No results posted yet for this 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.

Conditions

Interventions

DRUG

ARX788

Given IV

PROCEDURE

Computed Tomography (CT)

Undergo CT or Positron Emission Tomography(PET)/CT

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Amiloride

Ophthalmologic drops given topically to participants for an eye toxicity substudy

Sponsors & Collaborators

  • Ambrx, Inc.

    collaborator INDUSTRY

  • Laura Huppert, MD, BA

    lead OTHER

Principal Investigators

  • Laura Huppert, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2029-09-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06224673 on ClinicalTrials.gov