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Also known as JNJ-101684362 (HLD-0117)
JNJ-101684362 · 1 trial · 1 indication
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| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | JNJ-101684362 (HLD-0117): Participants with estrogen receptor positive (ER+) metastatic breast cancer (MBC) will receive JNJ-101684362 (HLD-0117) orally once daily as monotherapy in Part 1 until recommended dose(s) for expansion has been developed. Participants in Part 2 will receive JNJ-101684362 (HLD-0117) at the RP2Ds developed in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-101684362 (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), greater than or equal to (\>=) 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...
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JNJ-101684362 is an investigational small molecule being studied for the treatment of metastatic breast cancer. It is in Phase 1 clinical development and is being evaluated in adult female patients with this condition. It has not been established as a treatment outside of clinical research.
JNJ-101684362 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor of the Phase 1 study evaluating the compound in metastatic breast cancer.
JNJ-101684362 is in Phase 1 clinical development. It is an investigational agent and is not FDA approved. The single registered trial for the compound is currently recruiting participants, and no trials of JNJ-101684362 have been completed.
JNJ-101684362 is being studied in trial NCT07524855, titled A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer. The Phase 1 trial is recruiting up to 170 female participants aged 18 years and older across sites in the United States and Australia.
Yes, HLD-0117 is another designation for JNJ-101684362. The compound is referred to as JNJ-101684362 (HLD-0117), and the Phase 1 metastatic breast cancer trial NCT07524855 uses both names in its title, so searches for either name refer to the same investigational asset.
The NCT07524855 trial is an uncontrolled, open-label Phase 1 study, meaning it is not randomized and does not use a double-blind design or a control arm. It enrolls female patients aged 18 years and older with metastatic breast cancer and includes biomarker selection of participants.