A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer
A Phase 1 Study of JNJ-101684362 (HLD-0117) in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion 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 1. Must have received at least one endocrine therapy in the metastatic setting. 2. Must have received at least one cyclin-dependent kinase (CDK) 4/6i, either in the adjuvant and/or metastatic setting. 3. 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. 4. 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 1. For Part 1 and Part 2B, 2C, and 2E: Participants may have either evaluable or measurable disease per RECIST v1.1. 2. For Part 2 Cohort 2A: Participants should have measurable soft tissue disease per RECIST v1.1. 3. 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): 1. 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. 2. 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. 3. 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 Exclusion Criteria: * 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
Study sites (6)
CT
- Yale University School Of Medicine · New Haven, CT 06510More trials in New Haven
FL
- Florida Cancer Specialists · Sarasota, FL 34236More trials in Sarasota
MA
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
TN
- SCRI Oncology Partners · Nashville, TN 37203More trials in Nashville
TX
- South Texas Accelerated Research Therapeutics, LLC (START) · San Antonio, TX 78229More trials in San Antonio
VA
- Next Virginia · Fairfax, VA 22031More trials in Fairfax