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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06340568 | A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer | PHASE3 | RECRUITING | 480 | — | — | Jun 10, 2025 | Nov 1, 2029 | May 20, 2026 | 156 | United States, Argentina +22 |
By treatment arm. Defined as the time from randomization to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (HER2 IHC score 1+ or 2+): BNT323/DB-1303 | EXPERIMENTAL | - |
| Cohort 1 - Doxorubicin or paclitaxel (or docetaxel) | ACTIVE_COMPARATOR | Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice. Participants with contraindications to paclitaxel may receive docetaxel as an alternative (if available at the site). |
| Cohort 2 (HER2 IHC score 3+) - BNT323/DB-1303 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BNT323/DB-1303 | DRUG | intravenous (IV) infusion |
| Doxorubicin | DRUG | IV bolus or infusion |
| Paclitaxel | DRUG | IV infusion |
| Docetaxel | DRUG | IV infusion |
Key Inclusion Criteria: * Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent). * Have histologically confirmed endometrial cancer that: * Is recurrent, * Has a HER2 IHC score of 1+, 2+ (Cohort 1), o...