Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sofetabart Mipitecan · 1 trial · 4 indications
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
| 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. |
| 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 |
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 being studied for the treatment of ovarian cancer, including platinum-resistant and platinum-sensitive ovarian cancer. It is also being evaluated in related conditions such as fallopian tube neoplasms, peritoneal neoplasms, and neoplasm metastasis.
Sofetabart Mipitecan is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The drug is currently in Phase 3 clinical development for ovarian cancer.
Sofetabart Mipitecan is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. It has received Breakthrough Therapy designation from the FDA for its studied indication.
Sofetabart Mipitecan is being studied in a Phase 3 trial with the identifier NCT07213804. This three-part study enrolls participants with platinum-resistant and platinum-sensitive ovarian cancer and is currently recruiting in multiple countries, including the United States, Japan, and European nations.
The Phase 3 trial of Sofetabart Mipitecan is a randomized, active-controlled study that is not double-blinded. It is designed to evaluate the drug in participants with platinum-resistant ovarian cancer in Part A and platinum-sensitive ovarian cancer in Parts B and C. The trial plans to enroll 1,630 participants.