Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

ACE-Breast03 : A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM-1 or T-DXd, and/or Tucatinib-containing Regimens

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This Phase II trial is trying to understand the effectiveness of a new targeted therapy (ARX788) in people with HER2-positive metastatic breast cancer who have not responded to other targeted therapies (T-DM1, T-DXd, Tucatinib).
 

This trial is treating patients with HER2+ metastatic breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM-1 or T-DXd, and/or Tucatinib-containing Regimens

Commercial Sponsor

Ambrx, Inc.

Summary

This is a Phase II, open-label trial with one experimental arm, designed to assess the anti-cancer activity and safety of ARX788 in HER2+ metastatic breast cancer patients whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens. Participants will receive ARX788 every 4 weeks (Q4W) by intravenous infusion.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Breast and Gynaecology Research Study Coordinator
breastgynae.oncresearch@monashhealth.org
0491299561

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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