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Also known as JNJ-101684362 (HLD-0117)
JNJ-101684362 · 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 | 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 being studied for the treatment of metastatic breast cancer. It is an investigational small molecule in Phase 1 clinical development and has not been approved for any indication. The ongoing trial enrolls adult female patients with metastatic breast cancer in the United States.
JNJ-101684362 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor of the Phase 1 study evaluating the drug in patients with metastatic breast cancer.
JNJ-101684362 is in Phase 1 clinical development. It is an investigational small molecule and is not approved by the FDA. The single Phase 1 trial is currently recruiting participants with metastatic breast cancer.
JNJ-101684362 is being evaluated in one clinical trial, NCT07524855, titled A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer. The Phase 1 trial is recruiting and plans to enroll 170 female participants aged 18 years and older in the United States.
Yes, JNJ-101684362 is also known as HLD-0117. The two names refer to the same investigational small molecule being developed by Johnson & Johnson for metastatic breast cancer. The ongoing Phase 1 trial, NCT07524855, lists both names in its title.