NCT07524855

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_1

Timeline
37mo left

Started Apr 2026

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Apr 2026Oct 2029

First Submitted

Initial submission to the registry

April 6, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2029

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

2.1 years

First QC Date

April 6, 2026

Last Update Submit

September 16, 2026

Conditions

Metastatic Breast Cancer

Keywords

breast cancerRIPTACbreast carcinomalocally advanced breast cancerbreast tumormalignant Tumor of the breast

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicities (DLTs)

    Frequency of dose-limiting toxicities (DLTs)

    28 days

  • AEs, ECGs, Labs and Clinical Changes

    Frequency and severity of adverse events (AEs) and abnormal electrocardiogram (ECG), laboratory and clinical changes from baseline

    28 days

Secondary Outcomes (5)

  • Objective response rate (ORR)

    56 Days

  • Duration of response (DOR)

    28 days

  • Progression-free survival (rPFS)

    56 days

  • Disease Control Rate (DCR)

    24 weeks

  • Clinical Benefit Rate (CBR)

    24 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

Drug: JNJ-101684362 (HLD-0117)

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.)

Arm 1

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCisgender
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female (assigned at birth), greater than or equal to (\>=) 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 therapy including
  • Must have received at least one endocrine therapy in the metastatic setting.
  • Must have received at least one cyclin-dependent kinase (CDK) 4/6i, either in the adjuvant and/or metastatic setting.
  • For Part 1 and Part 2 Cohorts 2A, 2B, 2C, and 2D: Participants may have received up to two prior distinct cytotoxic regimens (for example, taxanes, antibody-drug conjugates (ADCs), etc.) in the metastatic setting, unless discussed and approved by the medical monitor.
  • For Part 2 Cohort 2E: Participants must have received more than two prior distinct cytotoxic regimens (for example, taxanes, ADCs, etc.) in the metastatic setting.
  • Radiologic disease progression on the most recent therapy
  • Patients must have disease evaluable per response evaluation criteria in solid tumors (RECIST) v1.1
  • For Part 1 and Part 2B, 2C, and 2E: Participants may have either evaluable or measurable disease per RECIST v1.1.
  • For Part 2 Cohort 2A: Participants should have measurable soft tissue disease per RECIST v1.1.
  • For Part 2 Cohort 2D: Participants should have evaluable but not measurable disease.
  • Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate
  • For Part 1 and Part 2 (all cohorts):
  • +7 more criteria

You may not qualify if:

  • Participants with Inflammatory breast cancer or leptomeningeal disease or brain metastases, with the exception of patients with definitively treated brain metastases that are clinically stable and asymptomatic for \>2 weeks and who are off or receiving low-dose corticosteroid treatment (\<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Yale University School Of Medicine

New Haven, Connecticut, 06510, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34236, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

South Texas Accelerated Research Therapeutics, LLC (START)

San Antonio, Texas, 78229, United States

RECRUITING

Next Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Phase 1 dose escalation will employ the BOIN design (to find the Maximum Tolerated Dose (MTD)/ Recommended Dose for Expansion (RDE)). The study enables backfilling patients to doses that are cleared for safety during the dose escalation.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

April 9, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

October 10, 2029

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(6)