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

Ambrx

Status and phase

Enrolling

Phase 2

Conditions

HER2 Positive Metastatic Breast Cancer

Treatments

Drug: ARX788

Study type

Interventional

Funder types

Industry

Identifiers

NCT04829604

ACE-Breast-03

Details and patient eligibility

About

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

Full 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.

Enrollment

71 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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