A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or … (NCT06857175) | Clinical Trial Compass
RecruitingPhase 3
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)
China508 participantsStarted 2025-03-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Sign the informed consent form voluntarily and follow the protocol requirements;
✓. Age: ≥18 years old;
✓. Expected survival time ≥3 months;
✓. Patients with unresectable locally advanced or metastatic urothelial carcinoma who had failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors;
✓. Patients with locally advanced or metastatic urothelial carcinoma who are eligible for treatment with the control chemotherapy agents specified in this protocol;
✓. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
✓. At least one measurable lesion meeting the RECIST v1.1 definition was required;
✓. ECOG 0 or 1;
Exclusion criteria
✕. Chemotherapy, targeted therapy, biological therapy, etc. were used within 4 weeks or 5 half-lives before randomization;
✕. Patients with locally advanced or metastatic urothelial carcinoma who were suitable for radical local therapy were excluded;
✕. Frontline received ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3; The front line had received both paclitaxel and docetaxel;
✕. History of severe heart disease and cerebrovascular disease;