Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elacestrant · 2 trials · 9 indications
Based on the observed number of dose-limiting toxicities (DLTs) during the first cycle. Dose-limiting toxicity is based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs will be evaluated during the first cycle (28 days) of treatment in up to 3 cohorts during Phase 1b. A DLT will be defined as any of the toxicities listed in the protocol that are not clearly due to breast cancer or extraneous causes.
Defined as the proportion of participants with a best overall response (BOR) of either a confirmed complete response (CR) or partial response (PR) per blinded independent central review (BICR).
| Arm | Type | Description |
|---|---|---|
| Subjects with normal hepatic function | EXPERIMENTAL | Subjects with normal hepatic function will receive treatment compared to subjects with severe hepatic function |
| Subjects with severe hepatic impaired function | EXPERIMENTAL | Subjects with severe hepatic function will receive treatment compared to subjects with normal hepatic function |
| Phase 1b Cohort 1 | EXPERIMENTAL | Elacestrant 300 milligrams (mg) once daily (QD) + abemaciclib 100 mg twice daily (BID) |
| Phase 1b Cohort 2 | EXPERIMENTAL | Elacestrant 400 mg QD + abemaciclib 100 mg BID |
| Phase 1b Cohort 3 | EXPERIMENTAL | Elacestrant 400 mg QD + abemaciclib 150 mg BID |
| Phase 2 | EXPERIMENTAL | Elacestrant in combination with abemaciclib at the RP2D determined in Phase 1b |
| Name | Type | Description |
|---|---|---|
| Elacestrant dihydrochloride | DRUG | A single oral dose of 200 mg elacestrant (2 x 100 mg tablets). |
| Elacestrant | DRUG | 300 mg, 400 mg |
| Abemaciclib | DRUG | 100 mg, 150 mg |
Inclusion Criteria: 1. Understand the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol restrictions and requirements. 2. Males and Females older than 18 years. 3. Body mass index between 18.0 and 40.0 kg/m\^2, inclusive. 4. Females must have no...
Elacestrant is an investigational small molecule being studied for use in breast neoplasms and hepatic impairment. In oncology, it is being evaluated in combination with abemaciclib for participants with brain metastasis due to ER+/HER2- breast cancer. A separate study assesses its pharmacokinetics in subjects with normal or severely impaired hepatic function.
Elacestrant is a selective estrogen receptor degrader (SERD), targeting the estrogen receptor. As a SERD, it works by binding to and degrading the estrogen receptor, which is relevant in estrogen receptor-positive breast cancer. This mechanism is being studied in the context of ER+/HER2- breast cancer with brain metastasis.
Elacestrant is being developed by cbdMD, Inc., which trades under the ticker YCBD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology and hepatic impairment indications.
Elacestrant is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are listed: one recruiting for breast cancer with brain metastasis and one completed study in hepatic impairment.
Elacestrant is being studied in two Phase 1 trials. NCT05386108 is a recruiting study of abemaciclib and elacestrant in participants with brain metastasis due to ER+/HER2- breast cancer, enrolling 73 participants across multiple countries. NCT06126575 is a completed pharmacokinetic study in subjects with normal or severely impaired hepatic function.
Elacestrant belongs to the class of selective estrogen receptor degraders (SERDs), which includes other drugs that target the estrogen receptor. However, Elacestrant is a distinct investigational compound being developed by cbdMD, Inc. for breast cancer and hepatic impairment indications.