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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06225596 | Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) | PHASE2 | ACTIVE NOT_RECRUITING | 375 | — | — | Jan 24, 2024 | Mar 1, 2028 | May 27, 2026 | 102 | United States, Argentina +19 |
The time from randomization to date of first documentation of disease progression or death.
The time from randomization to date of first documentation of disease progression or death.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Zelenectide pevedotin Arm 1 | EXPERIMENTAL | Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab. |
| Cohort 1: Zelenectide pevedotin Arm 2 | EXPERIMENTAL | Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab. |
| Cohort 1: Arm 3 | ACTIVE_COMPARATOR | Participants will receive Platinum-based combination chemotherapy +/- avelumab maintenance |
| Cohort 2: Zelenectide pevedotin Arm 1 | EXPERIMENTAL | Participants will receive zelenectide pevedotin. |
| Cohort 2: Zelenectide pevedotin Arm 2 | EXPERIMENTAL | Participants will receive zelenectide pevedotin. |
| Name | Type | Description |
|---|---|---|
| Zelenectide pevedotin | DRUG | Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle. |
| Pembrolizumab | DRUG | Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the zelenectide pevedotin infusion. |
| Gemcitabine + cisplatin Or carboplatin | DRUG | Participants will receive Gemcitabine on Days 1 and 8 of every 21-day cycle plus cisplatin Or carboplatin on Day 1 of every 21-day cycle. |
| Avelumab | DRUG | After 4-6 cycles of Gemcitabine + Cisplatin or Carboplatin participants will receive maintenance Avelumab, if clinically indicated, on Days 1 and 15 each 28-day cycle. |
Key Inclusion Criteria: * Life expectancy ≥ 12 weeks. * Measurable disease as defined by RECIST v1.1. * Histologically or cytologically confirmed locally advanced (unresectable) or metastatic UC of the renal pelvis, ureter, bladder, or urethra. * Archival or fresh tumor tissue comprising primary or...