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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07218809 | AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer | PHASE3 | RECRUITING | 1,100 | — | — | Dec 29, 2025 | May 27, 2030 | Jan 16, 2026 | 125 | United States, Australia +19 |
PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| AZD5335 in FRa-high cohort | EXPERIMENTAL | AZD5335 IV (intravenous) in FRa-high cohort |
| Mirvetuximab Soravtansine (MIRV) in FRa-high cohort | ACTIVE_COMPARATOR | MIRV AIBW IV in FRa-high cohort |
| AZD5335 in FRa-low cohort | EXPERIMENTAL | AZD5335 IV (intravenous) in FRa-low cohort |
| Investigator´s choice chemotherapy in FRa-low cohort | ACTIVE_COMPARATOR | Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor |
| Name | Type | Description |
|---|---|---|
| AZD5335 | DRUG | antibody drug conjugate |
| Mirvetuximab Soravtansine (MIRV) | DRUG | antibody drug conjugate |
| Paclitaxel | DRUG | chemotherapy |
| Pegylated liposomal Doxorubicin (PLD) | DRUG | chemotherapy |
| Topotecan | DRUG | chemotherapy |
Key Inclusion criteria * Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer. * Participants must have platinum-resistant disease: * Participants who have only had one prior line of platinum-based therapy must have received at least 4 ...