A Phase 1 Study of HLD-0117 in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)
Assessment of the safety and efficacy of HLD-0117 as monotherapy in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally advanced breast cancer that have progressed on prior systemic therapies.
• Female (assigned at birth), ≥18 years old, and able to provide informed consent
• Histologically confirmed metastatic or locally advanced breast cancer
• Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist
• Prior treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4/6 inhibitor (in the adjuvant and/or metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting
• Radiologic disease progression on the most recent therapy
• Measurable disease per RECIST v1.1
• Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate
• ER-positive and HER2-negative status documented within 2 years
• ECOG performance status 0-1 and life expectancy of at least 3 months
• Adequate organ function Recovery from prior therapy-related toxicities to Grade ≤1 (except alopecia; neuropathy and endocrinopathies ≤Grade 2)
• Ability to swallow oral medication and comply with study procedures
• Stable dose (≥30 days) of bisphosphonates or denosumab, if applicable