Actively Recruiting
A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
76
Participants Needed
1
Research Sites
240 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
Phase IIa/IIb clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system tumors.
CONDITIONS
Official Title
A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to follow study requirements
- Any gender
- Age between 18 and 75 years
- Expected survival of at least 3 months
- Diagnosed with locally advanced or metastatic urothelial carcinoma or other solid tumors confirmed by pathology after failure or intolerance to standard treatment or lack of available standard treatment
- For prostate cancer, testosterone levels below 1.73 nmol/L with disease progression before screening
- Agree to provide tumor tissue samples from primary or metastatic lesions within 3 years, or eligible by investigator assessment if samples are unavailable
- At least one measurable lesion (other than prostate cancer) as defined by RECIST v1.1
- ECOG performance status 0 or 1
- Toxicity from previous anti-cancer treatments resolved to grade 1 or less
- No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
- Adequate organ function
- Premenopausal women likely to have children must have a negative pregnancy test within 7 days before treatment and not be breastfeeding
- All participants advised to use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Received antineoplastic therapy within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks; oral fluorouracil drugs
- History of severe cardiovascular or cerebrovascular disease
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent uncontrollable arrhythmia
- Active autoimmune or inflammatory diseases
- Other malignant tumors progressed or treated within 5 years before first dose
- Poor blood glucose control before first dose
- Poorly controlled hypertension with two drugs or history of hypertensive crisis or encephalopathy
- History or suspicion of interstitial lung disease
- Pulmonary diseases causing severe respiratory impairment
- Long-term systemic corticosteroid or immunosuppressive therapy before first dose
- Unstable thrombotic events within 6 months
- Central nervous system metastases, carcinomatous meningitis, or spinal cord compression
- Massive or symptomatic effusions or poorly controlled effusions
- Tumor invading or wrapping large blood vessels in chest, neck, or pharynx that affects enrollment
- Allergy to recombinant humanized or human-mouse chimeric antibodies or BL-B01D1 components
- Prior organ or allogeneic stem cell transplantation
- Positive HIV antibody or active tuberculosis or hepatitis B or C infection
- Serious infection within 4 weeks or active pulmonary infection within 2 weeks before first dose
- Superior vena cava syndrome
- History of severe neurological or psychiatric disorders
- Serious unhealed wounds, ulcers, fractures, or significant bleeding within 4 weeks
- Scheduled to receive live vaccine within 28 days before first dose
- Other conditions deemed inappropriate by 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, 200032
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
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