Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07213804 | A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer | PHASE3 | RECRUITING | 1,080 | — | — | Oct 22, 2025 | Aug 1, 2031 | May 27, 2026 | 259 | United States, Australia +24 |
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: LY4170156 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. |
| 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 and B: * Have histologically confirmed high-grade serous or high-grade 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 system...