Metastatic Breast CancerPhase 1HLD-0117NCT07524855
A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer
A Phase 1 study testing JNJ-101684362 (HLD-0117) in people with Metastatic Breast Cancer, run by Janssen Research & Development, LLC at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- JNJ-101684362 (HLD-0117)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 9 Apr 2026to 15 Apr 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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):
- Participants must have documented >=10% ER staining and human epidermal growth factor receptor 2 (HER2) negative (per american society of clinical oncology [ASCO] college of american pathologists [CAP] guidelines) on the most recent tumor biopsy sample obtained.
- For Part 2 Cohort 2B: Participants must have recent estrogen receptor 1 gene (ESR1) wild type from tumor or circulating tumor deoxy ribonucleic acid (ctDNA) testing performed after the most recent endocrine therapy prior to enrollment.
- For Part 2 Cohort 2C: Participants must have ESR1 mutation detected from tumor or ctDNA testing performed prior to enrollment.
- Eastern cooperative oncology group (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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Next Virginia
Fairfax, Virginia, 22031
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Yale University School Of Medicine
New Haven, Connecticut, 06510
- Recruiting
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, 78229
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34236
About this study
Official title: A Phase 1 Study of JNJ-101684362 (HLD-0117) in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- JNJ-101684362 (HLD-0117)
- Keywords
- breast cancer, RIPTAC, breast carcinoma, locally advanced breast cancer, breast tumor, malignant Tumor of the breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JNJ-101684362 (HLD-0117) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs)
Frequency of dose-limiting toxicities (DLTs)
Measured: 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
Measured: 28 days
Secondary outcomes (5)
Objective response rate (ORR)
Objective response rate (ORR) per RECIST in evaluable patients
Measured: 56 Days
Duration of response (DOR)
DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first.
Measured: 28 days
Progression-free survival (rPFS)
Radiographic progression-free survival (rPFS)
Measured: 56 days
Disease Control Rate (DCR)
Disease Control Rate (DCR)
Measured: 24 weeks
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of patients who achieve partial response (PR) or complete response (CR), or stable disease (SD) lasting at least 24 weeks, as assessed according to RECIST v1.1.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start9 Apr 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion15 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524855
- Sponsor's protocol ID
- HLD-0117-ONC-101
- Other IDs
- HLD-0117-ONC-101, 2026-527749-23-00
- Acronym
- HLD-0117
- Status last verified
- Nov 2026
- First submitted
- 6 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of JNJ-101684362 (HLD-0117) in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT07524855
- Acronym / sponsor ID
- HLD-0117 / HLD-0117-ONC-101
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, RIPTAC, breast carcinoma, locally advanced breast cancer, breast tumor, malignant Tumor of the breast
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 15 Apr 2030 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: JNJ-101684362 (HLD-0117)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
- Radiologic disease progression on the most recent therapy
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.) | Drug | Arm 1 |
Primary outcome
Dose Limiting Toxicities (DLTs)
Time frame: 28 days
Frequency of dose-limiting toxicities (DLTs)
AEs, ECGs, Labs and Clinical Changes
Time frame: 28 days
Frequency and severity of adverse events (AEs) and abnormal electrocardiogram (ECG), laboratory and clinical changes from baseline
5 secondary outcomes
Objective response rate (ORR)
Time frame: 56 Days
Duration of response (DOR)
Time frame: 28 days
Progression-free survival (rPFS)
Time frame: 56 days
Disease Control Rate (DCR)
Time frame: 24 weeks
Clinical Benefit Rate (CBR)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-101684362 (HLD-0117) in people with Metastatic Breast Cancer, run by Janssen Research & Development, LLC at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLTs) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.