HLD-0117 treatment for ER-positive metastatic breast cancer
A Phase 1 Study of HLD-0117 in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)
This will test whether the oral drug HLD-0117 is safe and can shrink tumors in people with ER-positive metastatic or locally advanced breast cancer who have progressed after prior treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Halda Therapeutics OpCo, Inc. Industry-sponsored |
| Drugs / interventions | denosumab, prednisone |
| Locations | 3 sites (Sarasota, Florida and 2 other locations) |
| Trial ID | NCT07524855 on ClinicalTrials.gov |
What this trial studies
This is an open-label, first-in-human phase 1 study of oral HLD-0117 given as a single agent to patients with estrogen receptor–positive, HER2-negative metastatic or locally advanced breast cancer after prior systemic therapy. The trial uses a Bayesian optimal interval (BOIN) dose-escalation design with cohorts of at least three patients and allows backfilling into dose levels found to be safe, followed by cohort expansion at recommended doses. Key measurements include safety and tolerability, determination of the maximum tolerated dose and/or recommended dose(s) for expansion, pharmacokinetics and pharmacodynamics, and preliminary anti-tumor activity by RECIST v1.1. Mandatory baseline and on-treatment tumor biopsies are requested when feasible to support biomarker and PD assessments.
Who should consider this trial
Good fit: Ideal candidates are adults assigned female at birth, postmenopausal, with ER-positive/HER2-negative metastatic or locally advanced breast cancer, measurable disease, ECOG 0–1, progression after prior endocrine therapy and a CDK4/6 inhibitor, and willing to undergo baseline and on-treatment biopsies.
Not a fit: Patients who are HER2-positive, premenopausal without ovarian suppression, have poor performance status, significant organ dysfunction, or have received more than two prior cytotoxic regimens in the metastatic setting are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, HLD-0117 could become a new oral option that helps control tumor growth in patients with ER-positive metastatic breast cancer who have exhausted standard therapies.
How similar studies have performed: This approach is early-stage and while similar targeted small-molecule strategies have shown promise in preclinical work, clinical evidence for RIPTAC-like agents remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sarasota, Florida and 2 other locations
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- NEXT Oncology — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Study Information
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.