Actively Recruiting
A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-05-07
52
Participants Needed
1
Research Sites
100 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 study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 combination therapy in patients with locally advanced or metastatic urothelial carcinoma.
CONDITIONS
Official Title
A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 75 years
- Expected survival time of at least 3 months
- ECOG performance status of 0 or 1
- Confirmed unresectable locally advanced or metastatic urothelial carcinoma by histopathology or cytology
- No prior systemic therapy for locally advanced or metastatic urothelial cancer
- Archived tumor tissue or metastatic urothelial carcinoma biopsy sample available within 3 years for testing
- At least one measurable lesion according to RECIST v1.1
- Adequate organ function without recent blood transfusion or growth factor use within 14 days before first dose
- Previous treatment-related toxicity resolved to Grade 1 or less per NCI-CTCAE v5.0
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment, not lactating, and use of adequate barrier contraception during treatment and for 6 months after
You will not qualify if you...
- Prior antibody-drug conjugate treatment with TOPI inhibitors as toxin
- Palliative radiotherapy within 2 weeks before first dose
- Prior immunotherapy causing grade 3 or higher immune-related adverse events or grade 2 or higher immune-related myocarditis
- Use of immunomodulatory drugs within 14 days before first dose
- History of severe cardiovascular or cerebrovascular disease within past 6 months
- QT prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmia
- Active autoimmune or inflammatory diseases
- Long-term systemic corticosteroid therapy (prednisone 10mg/day or more)
- Other malignant tumors progressing or treated within 5 years before first dose
- Poorly controlled diabetes or severe diabetes complications
- Poorly controlled hypertension or history of hypertensive crisis
- History or current interstitial lung disease
- Severe respiratory impairment from pulmonary diseases
- Unstable thrombotic events requiring intervention within 6 months
- Active central nervous system metastases
- Massive or symptomatic effusions or poorly controlled effusions
- Allergy to recombinant humanized or human-mouse chimeric antibodies or test drug excipients
- Prior organ or allogeneic hematopoietic stem cell transplantation
- HIV positive or active tuberculosis, hepatitis B or C infection
- Serious infection or pulmonary inflammation within 4 weeks before first dose
- Participation in another clinical trial within 4 weeks before first dose
- Superior vena cava syndrome
- History of psychotropic substance abuse or severe neurological or psychiatric illness
- Tumor invasion or encasement of large thoracic vessels
- Severe unhealed wound, ulcer, or fracture within 4 weeks before consent
- Clinically significant bleeding or bleeding tendency within 4 weeks before consent
- Planned or recent live vaccine within 28 days before first dose
- Any other condition deemed inappropriate by the investigator for trial participation
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here