Actively Recruiting
Phase 1 Study of Oral HLD-0117 for Women With ER Metastatic or Locally Advanced Breast Cancer
Led by Halda Therapeutics OpCo, Inc. · Updated on 2026-06-02
33
Participants Needed
4
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of HLD-0117 as a single treatment in women with estrogen receptor positive ER metastatic or locally advanced breast cancer that has worsened after previous therapies. This open-label Phase 1 trial aims to find the best tolerated dose and recommended dose levels of HLD-0117 by studying its effects and how the body processes the drug. The study involves patients who have experienced progression following at least one prior systemic treatment. Participants will receive oral HLD-0117 as a single agent in 28-day treatment cycles. The study uses a dose-escalation design with small patient groups to determine safe dosage levels, potentially enrolling more patients at certain doses to better understand tolerability and treatment effects. Treatment continues until disease progression or other reasons require stopping, such as side effects or withdrawal of consent. During the study, patients will undergo regular monitoring including physical exams, lab tests, ECGs, and imaging to evaluate safety and response. Researchers will assess dose limiting toxicities, adverse events, and clinical changes over 28 days, and measure tumor response and disease control over several weeks. Participants are expected to provide tumor biopsies at baseline and during treatment if possible. The total duration includes treatment cycles and follow-up to monitor outcomes and safety.
CONDITIONS
Brief Title
A Study of HLD-0117 in Patients With Metastatic Breast Cancer
Research Team
S
Study Information
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