OncoMatch/Clinical Trials/NCT05965856
A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
Is NCT05965856 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and SI-B003 for urothelial carcinoma.
Treatment: BL-B01D1 · SI-B003 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Tumor Agnostic
Disease stage
Metastatic disease required
Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — urothelial carcinoma
Urothelial cancer should have received previous failure or intolerance to standard platinum-based chemotherapy
Must have received: novel hormonal therapy (abiraterone acetate, enzalutamide) — prostate cancer (adenocarcinoma)
Prostate cancer with pathological type of adenocarcinoma should have received at least one previous novel hormonal therapy (abiraterone acetate, enzalutamide, etc.)
Must have received: taxane (docetaxel, cabazitaxel) — prostate cancer (adenocarcinoma)
at least one failed or intolerant taxane regimen (docetaxel, cabazitaxel)
Must have received: tyrosine kinase inhibitor — clear cell renal cell carcinoma
Clear cell renal cell carcinoma required previous failure or intolerance to standard first-line tyrosine kinase inhibitor (TKI) regimens
Cannot have received: antibody-drug conjugate (topoisomerase I inhibitor payload)
Previous use of an ADC drug with a topoisomerase I inhibitor as a toxin
Lab requirements
Blood counts
hemoglobin ≥90g/L; absolute neutrophil count ≥1.5×10^9/L; platelet count ≥100×10^9/L
Kidney function
creatinine ≤1.5 ULN, or creatinine clearance ≥40 mL/min
Liver function
total bilirubin ≤1.5 ULN, ALT and AST ≤2.5 ULN (≤5.0 ULN with liver metastasis)
Cardiac function
no severe cardiac dysfunction with left ventricular ejection fraction ≥50%
organ function levels must meet the following criteria: ... see full text for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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