Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3295668 Erbumine · 3 trials · 3 indications
Number of Participants with DLTs
ORR
DoR
Part II: Number of Participants with DLTs
ORR: Percentage of participants who achieve CR or PR
PK: AUC of LY3295668 Erbumine
| Arm | Type | Description |
|---|---|---|
| LY3295668 Erbumine Escalation | EXPERIMENTAL | LY3295668 Erbumine given orally. |
| LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation | EXPERIMENTAL | LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV). |
| LY3295668 Erbumine Expansion | EXPERIMENTAL | LY3295668 Erbumine given orally. |
| LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion | EXPERIMENTAL | LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV. |
| LY3295668 Erbumine Part A | EXPERIMENTAL | LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. |
| LY3295668 Erbumine Part B | EXPERIMENTAL | LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam. |
| LY3295668 Erbumine + Endocrine Therapy Cohort 1 | EXPERIMENTAL | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II). |
| LY3295668 Erbumine + Endocrine Therapy Continuation Part C | EXPERIMENTAL | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). |
| LY3295668 Erbumine + Endocrine Therapy Switch Part D | EXPERIMENTAL | LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I). |
| LY3295668 Erbumine Cohort A | EXPERIMENTAL | LY3295668 erbumine administered orally. |
| LY3295668 Erbumine Cohort B | EXPERIMENTAL | LY3295668 erbumine administered orally. |
| LY3295668 Part JP | EXPERIMENTAL | LY3295668 erbumine administered orally. |
| Name | Type | Description |
|---|---|---|
| LY3295668 Erbumine | DRUG | Administered orally. |
| Topotecan | DRUG | Administered IV. |
| Cyclophosphamide | DRUG | Administered IV. |
| Endocrine therapy | DRUG | Administered according to label instructions. |
| Midazolam | DRUG | Administered orally. |
Inclusion Criteria: * Participants must have relapsed/refractory neuroblastoma and have active disease in at least one site: bone, bone marrow or soft tissue. Participants must be able to submit an archival sample of tissue. * Participants must be able to swallow capsules. Exclusion Criteria: * P...
LY3295668 Erbumine is an investigational small molecule being developed by Eli Lilly and Company for the treatment of several types of cancer. It is being studied in metastatic breast cancer, neuroblastoma, and small cell lung cancer. It is not yet approved and remains in Phase 1 clinical development.
LY3295668 Erbumine is being studied for metastatic breast cancer, neuroblastoma, and small cell lung cancer. These are the three cancer types evaluated in its clinical program. The drug is investigational, so it is not approved for any indication and is available only through clinical trials.
LY3295668 Erbumine is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical trials evaluating the compound in neuroblastoma, metastatic breast cancer, and small cell lung cancer.
LY3295668 Erbumine is in Phase 1 clinical development. All of its trials are Phase 1 studies, including one active trial in relapsed or refractory neuroblastoma and completed Phase 1 studies in metastatic breast cancer and extensive-stage small cell lung cancer. It is not FDA approved.
The active trial is NCT04106219, a Phase 1 study of LY3295668 Erbumine in participants with relapsed or refractory neuroblastoma, enrolling 71 patients across the United States, Australia, Belgium, France, Germany, Italy, Japan, Spain, and the United Kingdom. Completed Phase 1 trials include NCT03955939 in metastatic breast cancer and NCT03898791 in extensive-stage small cell lung cancer.
Yes. The LY3295668 Erbumine clinical program is biomarker selected, meaning trial enrollment is guided by a molecular biomarker rather than an unselected patient population. The Phase 1 studies in neuroblastoma, metastatic breast cancer, and small cell lung cancer all use this biomarker-based approach to identify appropriate participants.