Metastatic Breast Cancer study: JNJ-101684362
Official title A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07524855
What this study is testing
What is JNJ-101684362 (HLD-0117)?
JNJ-101684362 (HLD-0117) is an investigational medicine, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the highest dose that can be safely given and the recommended dose for later studies, while checking safety and how well participants tolerate the drug.
- Who it's for
- Adults who have metastatic breast cancer.
- What's involved
- Participants will receive the study drug at gradually increasing doses and undergo safety checks and other routine tests.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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.
You likely can't join if
- Participants with Inflammatory breast cancer or leptomeningeal disease or brain metastases, with the exception of patients with definitively treated...
- 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
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Sarasota, Florida, United States
- Boston, Massachusetts, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Adelaide, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States; Sarasota, Florida, United States; Boston, Massachusetts, United States; Nashville, Tennessee, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.