OncoMatch/Clinical Trials/NCT06857175
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma
Is NCT06857175 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BL-B01D1 and Docetaxel or Paclitaxel for urothelial carcinoma.
Treatment: BL-B01D1 · Docetaxel or Paclitaxel — This trial is a registered phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic urothelial carcinoma after failure of PD-1/PD-L1 monoclonal antibody and platinum-based chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Patients with unresectable locally advanced or metastatic urothelial carcinoma who had failed platinum-based chemotherapy
Must have received: anti-PD-1 therapy or anti-PD-L1 therapy
Patients with unresectable locally advanced or metastatic urothelial carcinoma who had failed ... PD-1/PD-L1 inhibitors
Cannot have received: antibody-drug conjugate targeting topoisomerase I inhibitors
Frontline received ADCs targeting topoisomerase I inhibitors
Cannot have received: EGFR inhibitor
Frontline received ... EGFR
Cannot have received: HER3 inhibitor
Frontline received ... HER3
Cannot have received: taxane (paclitaxel, docetaxel)
The front line had received both paclitaxel and docetaxel
Cannot have received: autologous or allogeneic stem cell transplant
Had a history of autologous or allogeneic stem cell transplantation
Lab requirements
Blood counts
If blood transfusion and colony-stimulating factor were not allowed within 14 days before randomization, the organ function level had to meet the requirements
Cardiac function
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; If blood transfusion and colony-stimulating factor were not allowed within 14 days before randomization, the organ function level had to meet the requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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