A Study of JNJ-101684362 (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

  • JNJ-101684362 (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

The purpose of this study is to find out the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of JNJ-101684362 (HLD-0117), to evaluate the safety of JNJ-101684362 (HLD-0117) , and how well the participants can tolerate it in Part 1 (dose escalation) of the study.

Key Dates

First listed
Apr 13, 2026
Start date
Apr 9, 2026
Status verified
Sep 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
    JNJ-101684362 (HLD-0117): Participants with estrogen receptor positive (ER+) metastatic breast cancer (MBC) will receive JNJ-101684362 (HLD-0117) orally once daily as monotherapy in Part 1 until recommended dose(s) for expansion has been developed. Participants in Part 2 will receive JNJ-101684362 (HLD-0117) at the RP2Ds developed in Part 1.

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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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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