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

Part of paid clinical trials in San Francisco, California.

Sponsor
Laura Huppert, MD, BA
Study ID
NCT06224673
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARX788 — DRUG
    Given IV
  • Computed Tomography (CT) — PROCEDURE
    Undergo CT or Positron Emission Tomography(PET)/CT
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Amiloride — DRUG
    Ophthalmologic drops given topically to participants for an eye toxicity substudy

Study Details

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.

Key Dates

Start date
Jun 5, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: HR+/HER2-low
    Participants with locally advanced, unresectable MBC that is hormone receptor (HR) positive (HR+) /human epidermal growth factor receptor 2 (HER2)-low will receive ARX788 intravenously over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, PET/CT, and collection of blood samples throughout the study.
  • Experimental: Cohort 2: HR-/HER2-low
    Participants with confirmed HR negative (HR-)/human epidermal growth factor receptor 2 (HER2)-low will receive ARX788 intravenously over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, PET/CT, and collection of blood samples throughout the study.
  • Experimental: Ocular Toxicity Prevention Sub-study
    The first 5 participants from Cohorts 1 and 2 will be given outpatient eye drops to use from home in conjunction with ARX788. Participants will be drop applied to each eye 4 times a day starting on the day of first infusion and continuing daily throughout treatment and for 30 days after the last infusion.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Amy Langdon
[email protected]
(415) 353-7288
[email protected]
877-827-3222
Laura Huppert, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California, San Francisco· San Francisco, CA

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