A Phase 1 Study of 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:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study Summary

Assessment of the safety and efficacy of HLD-0117 as monotherapy in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally advanced breast cancer that have progressed on prior systemic therapies.

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: Oral HLD-0117 administered as a single agent on a 28-day treatment cycle.
Drug: Drug: 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), ≥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 treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4/6 inhibitor (in the adjuvant and/or metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting
  • * Radiologic disease progression on the most recent therapy
  • * Measurable disease per RECIST v1.1
  • * Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate
  • * ER-positive and HER2-negative status documented within 2 years
  • * 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
  • Inflammatory breast cancer or known brain metastases
  • * 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