Actively Recruiting
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-04-20
508
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign the informed consent form voluntarily and follow the protocol requirements
- Be 18 years old or older
- Expected survival time of at least 3 months
- Have unresectable locally advanced or metastatic urothelial carcinoma after failure of platinum-based chemotherapy and PD-1/PD-L1 inhibitors
- Be eligible for treatment with the specified control chemotherapy agents
- Consent to provide archival or fresh tumor tissue samples within 3 years
- Have at least one measurable lesion according to RECIST v1.1
- Have an ECOG performance status of 0 or 1
- Previous antineoplastic therapy toxicity resolved to grade 1 or less
- No severe cardiac dysfunction with left ventricular ejection fraction of 50% or higher
- Organ function levels meeting requirements if no blood transfusion or colony-stimulating factor used within 14 days before randomization
- Negative serum pregnancy test within 7 days before treatment start for premenopausal women of childbearing potential and not lactating
- Use adequate barrier contraception during treatment and for 6 months after treatment ends
You will not qualify if you...
- Received chemotherapy, targeted therapy, biological therapy, or similar treatments within 4 weeks or 5 half-lives before randomization
- Suitable for radical local therapy for urothelial carcinoma
- Received frontline ADCs targeting topoisomerase I inhibitors, EGFR and/or HER3, or both paclitaxel and docetaxel
- History of severe heart disease or cerebrovascular disease
- Unstable thrombotic events requiring treatment within 6 months before screening
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmia
- Active malignancy diagnosed within 3 years before randomization
- Poorly controlled hypertension despite two antihypertensive drugs
- Poor glycemic control
- Grade 1 or higher radiation pneumonitis or history/suspicion of interstitial lung disease
- Pulmonary diseases causing severe respiratory impairment
- Active central nervous system metastases
- Severe infection within 4 weeks or active pulmonary infection within 2 weeks before randomization
- Massive, symptomatic, or poorly controlled effusions
- Tumor invading or wrapping large blood vessels in certain body areas unless deemed acceptable by the investigator
- Serious unhealed wounds, ulcers, or fractures within 4 weeks before consent
- Clinically significant bleeding or bleeding tendency within 4 weeks before consent
- Inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction, or chronic diarrhea
- History of allergy to recombinant humanized antibodies or any BL-B01D1 excipients
- History of autologous or allogeneic stem cell transplantation
- Positive for HIV antibodies or active hepatitis B or C infection
- Severe neurological or psychiatric illness history
- Received other unmarketed investigational drugs or treatments within 4 weeks before randomization
- Planned or recent live vaccination within 28 days before randomization
- Any other conditions considered inappropriate for trial participation by the investigator due to complications or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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