Actively Recruiting
A Phase III Randomized Controlled Study Comparing BL-B01D1 With Physician's Choice Chemotherapy in Patients With Recurrent or Metastatic Urothelial Carcinoma After PD-1/PD-L1 and Platinum Therapy
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-04-20
508
Participants Needed
1
Research Sites
26 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
Researchers are evaluating the efficacy and safety of BL-B01D1 in people with recurrent or metastatic urothelial carcinoma who have not responded to prior PD-1/PD-L1 monoclonal antibody and platinum-based chemotherapy. This phase III, randomized, open-label, multicenter study compares BL-B01D1 with chemotherapy selected by the physician. The goal is to better understand treatment outcomes for patients facing this advanced bladder cancer after other therapies have failed. Participants receive either BL-B01D1 or one of two chemotherapy drugs, Docetaxel or Paclitaxel, administered by intravenous infusion every 3 weeks. Those who benefit from the initial cycle may continue treatment for additional cycles unless disease progression, unacceptable side effects, or other reasons require stopping. Both treatment options follow the same cycle length and administration method. During the study, participants will be monitored for up to about 24 months to assess progression-free survival and overall survival as the main outcomes. Secondary assessments include response rates, disease control, duration of response, treatment side effects, and immune reaction against the drug. Researchers will also evaluate tumor samples and health status through regular visits and tests throughout the study period. Safety and treatment effects will be carefully tracked during and after treatment.
CONDITIONS
Brief 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...
- Signed informed consent and willing to follow study protocol
- Age 18 years or older
- Expected survival time of at least 3 months
- Diagnosed with unresectable locally advanced or metastatic urothelial carcinoma after failure of platinum-based chemotherapy and PD-1/PD-L1 inhibitors
- Eligible for treatment with control chemotherapy agents in this study
- Consent to provide tumor tissue samples within the past 3 years
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 or 1
- Previous treatment toxicities resolved to grade 1 or less
- No severe cardiac dysfunction with left ventricular ejection fraction 50% or higher
- Organ function meets requirements if no recent blood transfusion or colony-stimulating factor use
- Negative pregnancy test within 7 days before treatment for premenopausal women; not lactating
- Use adequate contraception during treatment and for 6 months after
You will not qualify if you...
- Received chemotherapy, targeted therapy, or biological therapy within 4 weeks or 5 half-lives before randomization
- Suitable for radical local therapy
- Prior use of ADCs targeting topoisomerase I inhibitors or EGFR/HER3, or both paclitaxel and docetaxel frontline
- History of severe heart or cerebrovascular disease
- Unstable thrombotic events requiring treatment within 6 months
- Prolonged QT interval, complete left bundle branch block, grade III AV block, or frequent uncontrollable arrhythmia
- Active malignancy within 3 years before randomization
- Poorly controlled hypertension despite two medications
- Poor blood sugar control
- Grade 1 or higher radiation pneumonitis, previous or suspected interstitial lung disease
- Severe respiratory impairment due to lung disease
- Active central nervous system metastases
- Severe infection within 4 weeks or pulmonary infection/inflammation within 2 weeks
- Large or symptomatic fluid buildup not controlled
- Tumor invading or wrapping major blood vessels if affecting enrollment
- Unhealed wounds, ulcers, or fractures within 4 weeks
- Significant bleeding or bleeding tendency within 4 weeks
- Inflammatory bowel disease or related serious bowel conditions
- Allergy to recombinant humanized antibodies or BL-B01D1 ingredients
- History of stem cell transplantation
- HIV positive or active hepatitis B or C infection
- Severe neurological or psychiatric illness
- Use of unmarketed investigational drugs within 4 weeks
- Planned or recent live vaccination within 28 days
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 3-week cycles until disease progression or discontinuation.
Participants receive either BL-B01D1 or chemotherapy with Docetaxel or Paclitaxel administered by intravenous infusion in cycles of 3 weeks. Treatment continues for additional cycles if there is clinical benefit and stops upon disease progression, intolerable toxicity, or other reasons.
1 visit per treatment cycle (in-person)
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
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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