Oncology Clinical Trial Finder
Breast Cancer

Recruiting • Phase II • Stage IV • Post-Menopausal • Brain Metastases present • Interventional

The following is imported from ClinicalTrials.gov:

ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd

A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Breast Cancer

Study Design
Study type:


Estimated enrollment:

71 participant

Actual study start date:

October 26, 2021

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:


Arms and Intervention
  • ARX788

Inclusion criteria
  • age ≥ 18 years and older

  • life expectancy ≥ 6 months

  • unresectable or metastatic breast cancer subjects

  • presence of at least one measurable lesion per recist v 1.1

  • subjects must have an adequate tumor sample available for confirmation of her2 status

  • subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment in the metastatic setting. one of these prior treatments must have been treatment with t-dxd.

  • subjects with stable brain metastases

  • acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to grade ≤1 as per the nci-ctcae v 5.0, except alopecia

  • adequate organ functions

  • willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol

  • key

Exclusion criteria
  • any subject who meets any of the following criteria is excluded from the study:

  • history of allergic reactions to any component of arx788.

  • prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease

  • any active ocular infections or chronic corneal disorders

  • history of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia within 12 months prior to enrollment

  • grade 3 to 4 peripheral neuropathy (nci ctcae v 5.0). patients with grade 2 neuropathy can be enrolled at investigator's discretion

  • history of unstable central nervous system (cns) metastases

  • current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases)

  • any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic covid-19 infections), or other conditions that could limit study compliance or interfere with assessments

  • exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of arx788

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:


Estimated Enrollment:


Last Updated:


Trial Contact

Trial Inquiry


(858) 875-2400

Principal Investigator


Trial Sponsor

Ambrx, Inc.

Study Location (133)

Virginia Oncology Associates

Norfolk, Virginia, United States

Washington University School of Medicine

Saint Louis, Missouri, United States

Tennessee Oncology

Nashville, Tennessee, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Providence Portland Medical Center

Portland, Oregon, United States


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