A Study of HLD-0117 in Patients With Metastatic Breast Cancer
ConditionMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHalda Therapeutics OpCo, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- HLD-0117
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov