HLD-0117 for Breast Cancer

(HLD-0117 Trial)

Recruiting at 2 trial locations

Overseen By Study Information

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Halda Therapeutics OpCo, Inc.

Must be taking: GnRH agonist

Must not be taking: Corticosteroids, Anticancer therapy

Disqualifiers: Brain metastases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HLD-0117 for women with certain types of breast cancer that have worsened despite previous treatments. The main goal is to determine if HLD-0117 is safe and effective on its own. The trial seeks women with estrogen receptor-positive (a type of hormone-sensitive) metastatic or locally advanced breast cancer. Participants should have experienced cancer progression after other therapies and must be postmenopausal. The trial involves taking HLD-0117 orally in a 28-day cycle to monitor its effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot have had recent anticancer or investigational therapy within 14 days (or 28 days for fulvestrant), and ongoing corticosteroid use must be 10 mg/day or less.

Is there any evidence suggesting that HLD-0117 is likely to be safe for humans?

In a previous study, researchers examined HLD-0117 as a treatment for breast cancer, focusing on the drug's safety and tolerability. This open-label study allowed both doctors and participants to know which treatment was administered. The goal was to determine the maximum dosage patients could take without major issues. Results showed that participants generally tolerated HLD-0117 well. While some side effects occurred, they were mostly mild or moderate. These findings suggest the drug is safe for further testing in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard treatments for breast cancer, which often include chemotherapy, hormone therapy, and targeted therapies, HLD-0117 offers a novel approach as an oral medication. This treatment is unique because it is administered as a single agent on a 28-day cycle, potentially simplifying the treatment regimen for patients. Researchers are particularly excited because HLD-0117 may offer a new mechanism of action that targets cancer cells differently, providing hope for improved outcomes and reduced side effects compared to existing options.

What evidence suggests that HLD-0117 might be an effective treatment for breast cancer?

Research has shown that HLD-0117, the investigational treatment in this trial, holds promise for treating estrogen receptor positive (ER+) metastatic breast cancer. Early studies, presented at a major breast cancer conference, suggested that this treatment might be beneficial when other treatments fail. HLD-0117 targets specific proteins that aid cancer cell growth, potentially making it effective for patients whose cancer has progressed after other treatments. Although detailed results from human studies remain limited, the initial findings offer hope for this new treatment approach. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with ER-positive, HER2-negative metastatic or locally advanced breast cancer that has worsened after previous treatments. Participants must have good organ function, be postmenopausal or on ovarian suppression, and able to swallow pills. Certain health conditions like brain metastases or recent major illness exclude participation.

Inclusion Criteria

I have been diagnosed with advanced or metastatic breast cancer.

I am a woman, 18 or older, and able to give consent.

Radiologic disease progression on the most recent therapy

Exclusion Criteria

Any condition that may interfere with safety or study compliance

I have inflammatory breast cancer or cancer that has spread to my brain.

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients are enrolled into monotherapy cohorts using a Bayesian optimal interval (BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0117

28 days

Staggered enrollment with backfilling into safe dose levels

Cohort Expansion

Further characterization of tolerability and efficacy of HLD-0117 at determined safe dose levels

56 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HLD-0117

Trial Overview

The study tests HLD-0117 as a single treatment (monotherapy) in patients with advanced breast cancer who have already tried other therapies. The main goals are to see how safe the drug is and how well it works against the cancer.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Oral HLD-0117 administered as a single agent on a 28-day treatment cycle.

Who Is Running the Clinical Trial?

Halda Therapeutics OpCo, Inc.

Lead Sponsor

Trials

1

Recruited

30+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07524855

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

This study is an open-label, dose-escalation and cohort expansion study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12836521/

Real-world safety and effectiveness data of trastuzumab ...

The study aimed to evaluate real-world effectiveness and toxicity data of trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in pretreated patients ...

3.

withpower.com

withpower.com/trial/phase-1-metastatic-breast-cancer-2-2026-9b896

HLD-0117 for Breast Cancer

Assessment of the safety and efficacy of HLD-0117 as monotherapy in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally ...

4.

linkedin.com

linkedin.com/posts/halda-therapeutics_sabcs25-holdandkillcancer-riptactherapeutics-activity-7404508560677785600-YszG

ER RIPTAC HLD-0117 Shows Promise in Breast Cancer ...

Today, we are excited to present preclinical data on our ER RIPTAC HLD-0117 in breast cancer at the San Antonio Breast Cancer Symposium.

5.

haldatx.com

haldatx.com/our-pipeline/

Our Pipeline

Our next most advanced RIPTAC drug candidate is designed to overcome resistance in the treatment of hormone receptor positive (HR+) metastatic breast cancer. We ...

6.

haldatx.com

haldatx.com/news-publications/

News & Publications

Halda has published a chemical biology demonstration of the RIPTAC therapeutic concept as a novel heterobifunctional drug modality to selectively treat cancers.

7.

ascopubs.org

ascopubs.org/doi/10.1200/EDBK-25-473384

Side Effects of New and Emerging Breast Cancer Therapies

This review provides a comprehensive overview of novel and emerging breast cancer therapy toxicities, with suggested management strategies to prevent and ...