Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HLD-0117 · 1 trial · 1 indication
Frequency of dose-limiting toxicities (DLTs)
Frequency and severity of adverse events (AEs) and abnormal electrocardiogram (ECG), laboratory and clinical changes from baseline
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Oral HLD-0117 administered as a single agent on a 28-day treatment cycle. |
| Name | Type | Description |
|---|---|---|
| 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.) |
Inclusion Criteria: * 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 treatmen...
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HLD-0117 is an investigational small molecule being developed for the treatment of metastatic breast cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with metastatic breast cancer, with a clinical trial actively recruiting participants in the United States.
HLD-0117 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for metastatic breast cancer, with an active clinical trial recruiting patients in the United States.
HLD-0117 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is actively recruiting participants with metastatic breast cancer in the United States, with a planned enrollment of 170 patients.
HLD-0117 is being studied in a Phase 1 clinical trial with the identifier NCT07524855, titled "A Study of HLD-0117 in Patients With Metastatic Breast Cancer." The trial is currently recruiting female patients aged 18 years and older with metastatic breast cancer in the United States, with a target enrollment of 170 participants.
No, HLD-0117 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for metastatic breast cancer. The drug is being evaluated in an active clinical trial, but it has not yet completed the clinical development process required for regulatory approval.