NCT05965856 A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
| NCT ID | NCT05965856 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sichuan Baili Pharmaceutical Co., Ltd. |
| Condition | Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2023-12-11 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This phase II study is designed to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with locally advanced or metastatic urothelial carcinoma and other solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. All subjects voluntarily participated in the study and signed informed consent; 2. Male or female aged ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG 0-1; 5. Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology who have failed or cannot tolerate standard treatment or who currently have no standard treatment or cannot obtain standard treatment; (including but not limited to urothelial cancer, prostate cancer, kidney cancer) : ① Urothelial cancer should have received previous failure or intolerance to standard platinum-based chemotherapy; ② Prostate cancer with pathological type of adenocarcinoma should have received at least one previous novel hormonal therapy (abiraterone acetate, enzalutamide, etc.) and at least one failed or intolerant taxane regimen (docetaxel, cabazitaxel); ③ Clear cell renal cell carcinoma required previous failure or intolerance to standard first-line t