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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05965856 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate (topoisomerase I inhibitor payload) disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages