NCT07524855 A Study of HLD-0117 in Patients With Metastatic Breast Cancer
| NCT ID | NCT07524855 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2026-04-09 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 33 participants in total. It began in 2026-04-09 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07524855 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07524855 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07524855 currently recruiting?
Yes, NCT07524855 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07524855 trial being conducted?
This trial is being conducted at New Haven, United States, Sarasota, United States, Nashville, United States, Fairfax, United States.
Who is sponsoring the NCT07524855 clinical trial?
NCT07524855 is sponsored by Janssen Research & Development, LLC. The trial plans to enroll 33 participants.
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