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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07044336 | Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) | PHASE3 | RECRUITING | 700 | — | — | Aug 1, 2025 | Jul 17, 2029 | May 20, 2026 | 314 | United States, Argentina +26 |
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
OS is defined as the time from randomization until the date of death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Puxitatug Samrotecan | EXPERIMENTAL | Puxi-Sam IV (intravenous) Q3W . |
| Chemotherapy | ACTIVE_COMPARATOR | Physician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles. |
| Name | Type | Description |
|---|---|---|
| Puxitatug Samrotecan | DRUG | 2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion |
| Doxorubicin | DRUG | 60 mg/m2 on Day 1 Q3W Route of administration: IV |
| Paclitaxel | DRUG | 80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV |
The main inclusion criteria include but are not limited to the following: * Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma. * Recurrent/metastatic EC ie, with radiological or objective evidence of recurrence or progression. * Has received prior platinum-based chemothe...