Bolivar, Missouri 65613

  • HER2 Positive Metastatic Breast Cancer

Purpose:

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


Study summary:

A Global, Single Arm, 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. The ARX788 will be administered every 4 weeks (Q4W) intravenous (IV) infusion.


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.


NCT ID:

NCT04829604


Primary Contact:

Study Director
Ambrx
Ambrx, Inc.

Trial Inquiry
Phone: (858) 875-2400
Email: breast03trialinquiry@ambrx.com


Backup Contact:

N/A


Location Contact:

Bolivar, Missouri 65613
United States

Tony Romero, MS CCRC
Phone: 402-697-2229
Email: tony@xcancer.us

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 04, 2021

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