A Phase 1 Study of JNJ-101684362 (HLD-0117) in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)

Study Identifier:
HLD-0117-ONC-101
CT.gov Identifier:
NCT07524855
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2026-527749-23-00
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancers
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Arm 1
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Drug: 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: Drug: 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 Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Will Be Recruiting
Condition(s) Treated at Site
Breast Cancers