A Study of HLD-0117 in Patients With Metastatic Breast Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07524855
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HLD-0117 — DRUG
    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.)

Study Details

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 Dates

First listed
Apr 13, 2026
Start date
Apr 9, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2028
Completion
Oct 10, 2029

Study Design

Enrollment
170 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Oral HLD-0117 administered as a single agent on a 28-day treatment cycle.

Primary Outcome Measure

Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Yale University School Of MedicineNew HavenConnecticut06510-
Florida Cancer SpecialistsSarasotaFlorida34236-
Massachusetts General HospitalBostonMassachusetts02114-
SCRI Oncology PartnersNashvilleTennessee37203-
South Texas Accelerated Research Therapeutics, LLC (START)San AntonioTexas78229-
Next VirginiaFairfaxVirginia22031-

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Breast cancer
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OncologyBreast oncologyWomen's health
By research site
Yale University School Of Medicine· New Haven, CTFlorida Cancer Specialists· Sarasota, FLMassachusetts General Hospital· Boston, MASCRI Oncology Partners· Nashville, TNSouth Texas Accelerated Research Therapeutics, LLC (START)· San Antonio, TXNext Virginia· Fairfax, VA

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