Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sofe-M, LY4170156
Sofetabart Mipitecan · 2 trials · 10 indications
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Number of participants with dose-limiting toxicities (DLTs)
Number of participants with DLTs
Number of participants with DLTs
Number of participants with DLTs
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
ORR per RECIST 1.1
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Part A: Sofetabart Mipitecan | EXPERIMENTAL | Administered intravenously (IV). |
| Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV) | ACTIVE_COMPARATOR | Investigator's Choice of Chemotherapy or MIRV given IV. |
| Part B: Sofetabart Mipitecan plus Bevacizumab | EXPERIMENTAL | Administered IV. |
| Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab | ACTIVE_COMPARATOR | Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV. |
| Part C: Sofetabart Mipitecan plus Bevacizumab | EXPERIMENTAL | Administered IV |
| Part C: Platinum-based Doublet Chemotherapy plus Bevacizumab | ACTIVE_COMPARATOR | Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV. |
| Sofe-M (Dose-escalation, Cohort A1) | EXPERIMENTAL | Escalating doses of Sofe-M administered intravenously (IV) |
| Sofe-M (Cohort A1 Parts A and C) | EXPERIMENTAL | Sofe-M administered IV |
| Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B) | EXPERIMENTAL | Sofe-M administered IV and itraconazole administered orally |
| Sofe-M (Dose-optimization, Cohort A2) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV |
| Sofe-M (Enrichment Cohort A3) | EXPERIMENTAL | Monotherapy administered IV |
| Sofe-M (Combination Cohort A4) | EXPERIMENTAL | Combination with bevacizumab administered IV |
| Sofe-M (Combination Cohort A5) | EXPERIMENTAL | Combination with carboplatin administered IV |
| Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with pembrolizumab |
| Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with or without bevacizumab |
| Sofe-M (Dose-expansion, Cohort B2-B4) | EXPERIMENTAL | Sofe-M administered IV |
| Sofe-M (Dose-expansion, Cohort B1) | EXPERIMENTAL | Sofe-M administered IV |
| Name | Type | Description |
|---|---|---|
| Sofetabart Mipitecan | DRUG | Administered IV |
| Paclitaxel | DRUG | Administered IV |
| Topotecan | DRUG | Administered IV |
| Gemcitabine | DRUG | Administered IV |
| Pegylated liposomal doxorubicin (PLD) | DRUG | Administered IV |
| MIRV | DRUG | Administered IV |
| Bevacizumab | DRUG | Administered IV |
| Carboplatin | DRUG | Administered IV |
| Sofe-M | DRUG | Intravenous |
| Itraconazole | DRUG | oral |
| pembrolizumab | DRUG | IV |
Inclusion Criteria: Part A, B, and C: * Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer. * Have confirmed availability of tumor tissue block or slides * Have radiographic progression on or after most recent line of systemic anti...
Sofetabart Mipitecan is an investigational small molecule oncology drug being developed by Eli Lilly and Company for the treatment of ovarian neoplasms. It is also known as Sofe-M. It is currently in Phase 3 clinical development and has received Breakthrough Therapy designation from the FDA.
Sofetabart Mipitecan is being studied for ovarian neoplasms, including platinum-resistant and platinum-sensitive ovarian cancer. Clinical trials also include fallopian tube neoplasms, peritoneal neoplasms, and metastatic disease, as well as a Phase 1 study in selected advanced solid tumors such as endometrial, cervical, and lung cancers.
Sofetabart Mipitecan is being 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 development program for the drug.
Sofetabart Mipitecan is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program is actively recruiting, and the drug has received Breakthrough Therapy designation from the FDA for its development in ovarian neoplasms.
Sofetabart Mipitecan is being evaluated in two active recruiting trials. NCT07213804 is a three-part Phase 3 study in platinum-resistant and platinum-sensitive ovarian cancer with planned enrollment of 1,630 participants. NCT06400472 is a Phase 1 study in selected advanced solid tumors with planned enrollment of 575 participants.
Yes, Sofetabart Mipitecan is also known as Sofe-M. Both names refer to the same investigational small molecule developed by Eli Lilly and Company. The Phase 1 trial in selected advanced solid tumors is listed under the Sofe-M name.