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RECRUITING
NCT07524855
PHASE1

A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1 Study of JNJ-101684362 (HLD-0117) in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2026-04-09

Completion Date

2029-10-10

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

JNJ-101684362 (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.)

Locations (6)

Yale University School Of Medicine

New Haven, Connecticut, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

South Texas Accelerated Research Therapeutics, LLC (START)

San Antonio, Texas, United States

Next Virginia

Fairfax, Virginia, United States