Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • 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.)

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Arm 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicities (DLTs)

Frequency of dose-limiting toxicities (DLTs)

Time frame
28 days
2

AEs, ECGs, Labs and Clinical Changes

Frequency and severity of adverse events (AEs) and abnormal electrocardiogram (ECG), laboratory and clinical changes from baseline

Time frame
28 days

Secondary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) per RECIST in evaluable patients

Time frame
56 Days
2

Duration of response (DOR)

Duration of response (DOR)

Time frame
28 days
3

Progression-free survival (rPFS)

Radiographic progression-free survival (rPFS)

Time frame
56 days
4

Disease Control Rate (DCR)

Disease Control Rate (DCR)

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Halda Therapeutics OpCo, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now