NCT04829604

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Ambrx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• HER2 Positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	ARX788	The active pharmaceutical ingredient in ARX788 is an antibody drug conjugate (ADC) consisting of a humanized anti-HER2 monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two microtubule-disrupting payloads AS269

Timeline

• Start date: 2021-10-26
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2021-04-02
• Last updated: 2026-03-09

Locations

33 sites across 3 countries: United States, Australia, South Korea

Regulatory

• FDA-regulated drug study