Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Samuraciclib · 1 trial · 3 indications
CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from randomization until disease progression, or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. |
| Arm B | EXPERIMENTAL | Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15. |
| Arm C | EXPERIMENTAL | Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15. |
| Name | Type | Description |
|---|---|---|
| Samuraciclib | DRUG | Samuraciclib tablet by mouth once a day |
| Fulvestrant | DRUG | Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15 |
Inclusion Criteria: * Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer. * Documented objective disease progression while on or within 6 months after the end of the most recent therapy. * Received prior AI in combination with a CDK4/6i as ...
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Samuraciclib is an investigational small molecule being studied for the treatment of metastatic breast cancer and locally advanced breast cancer. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Samuraciclib is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research to evaluate the drug's safety and efficacy in breast cancer patients.
Samuraciclib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials for the treatment of metastatic and locally advanced breast cancer.
Samuraciclib has one completed Phase 2 clinical trial registered as NCT05963984. This study evaluated Samuraciclib in combination with fulvestrant in adult participants with metastatic or locally advanced breast cancer, enrolling 60 participants across the United States, Hungary, Mexico, Spain, and Turkey.
Samuraciclib is not known to have alternative names. It is a distinct investigational small molecule being studied for breast cancer, and no other names for this drug have been reported.