Recruiting
Phase 1

HLD-0117

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07524855

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HLD-0117

Study Details

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.

Conditions

Metastatic Breast Cancer

Study ID

NCT07524855

Start date

Apr 9, 2026

Status verified date

Aug, 2026

Completion date

Oct 10, 2029

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Oral HLD-0117 administered as a single agent on a 28-day treatment cycle.

Interventions

HLD-0117

A treatment cycle consists of 28 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)

Primary outcome measure

  • Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days ]
  • AEs, ECGs, Labs and Clinical Changes [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Yale University School Of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34236

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

South Texas Accelerated Research Therapeutics, LLC (START)

Recruiting

San Antonio, Texas, United States, 78229

Next Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • breast cancer
  • RIPTAC
  • breast carcinoma
  • locally advanced breast cancer
  • breast tumor
  • malignant Tumor of the breast

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-17.