A Study of HLD-0117 in Patients With Metastatic Breast Cancer
Recruiting now · Phase 1
Conditions studied: Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07524855
- Run by
- Janssen Research & Development, LLC
- People needed
- 33
- Starts
- 2026-04-09
- Expected to finish
- 2028-04-30
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Inflammatory breast cancer or known brain metastases
- Recent major bleeding or uncontrolled bleeding disorder
- Ongoing corticosteroid use >10 mg/day (prednisone equivalent)
- Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant)
- Untreated or unstable spinal cord compression
- Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions
- Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed)
- Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases)
- Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers)
- Major surgery within 28 days
- Any condition that may interfere with safety or study compliance
- Pregnancy or breastfeeding
Where it is running
- Yale- New Haven Hospital- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- NEXT Oncology — Fairfax, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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