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

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients whose Disease is Resistant or Refractory to T-DM1, and/or T-DXd, and/or Tucatinib-containing Regimens

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ambrx, Inc.
• Treatments: Immunoconjugates

Criteria

Inclusion Criteria:

• Age ≥ 18 years and older

• Life expectancy > 3 months

• Eastern Cooperative Oncology Group Performance Status ≤ 1

• Metastatic breast cancer subjects previously treated with T DM1, and/or T-DXd, and/or tucatinib-containing regimens.

• 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 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.

• Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at postmenopausal, or who commits to use an acceptable form of birth control; male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control

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 within 12 months

• History of ocular events, or any current ongoing active ocular infections.

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

• Grade 2 to 4 peripheral neuropathy (NCI CTCAE v 5.0)

• 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.

• Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788

• Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0.

• Pregnancy or breast feeding.

• Known active HCV, HBV, and/or HIV infection.