NCT07524855

A Study of HLD-0117 in Patients With Metastatic Breast Cancer

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Halda Therapeutics OpCo, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is an open-label, dose-escalation and cohort expansion study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of oral single-agent, HLD-0117 in patients with ER+ MBC that have progressed after at least 1 prior systemic line of therapy. During dose escalation, patients will be enrolled into monotherapy cohorts using a Bayesian optimal interval (BOIN) design. Cohorts will enroll a minimum of three patients, with staggered enrollment between cohorts. Backfilling into dose levels determined to be safe may occur to further characterize tolerability and efficacy. The purpose of the study is to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0117 as a monotherapy.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	HLD-0117	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.)

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study