Testing JNJ-101684362 safety and dose in breast cancer

Trial details

Who runs it

Janssen Research & Development, LLC

Trial code

NCT07524855EU 2026-527749-23-00

Record updated

3 November 2026

Original description

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 full original descriptionShow less

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.

Inclusion: 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):; 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.

Exclusion: 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; Ongoing corticosteroid use >10 mg/day (prednisone equivalent); Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant); Major surgery within 28 days; Recent major bleeding or uncontrolled bleeding disorder; 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); Any condition that may interfere with safety or study compliance; Untreated or unstable spinal cord compression; Pregnancy or breastfeeding.

ClinicalTrials.gov NCT07524855 · EU CTIS 2026-527749-23-00