Actively Recruiting
A Study of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-18
21
Participants Needed
1
Research Sites
101 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 an open, multicenter, dose-escalation and expansion-enrollment and nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-B16D1 in locally advanced or metastatic solid tumors.
CONDITIONS
Official Title
A Study of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreement to follow study protocol
- Any gender
- Age 18 to 75 years for Phase Ia; 18 years and older for Phase Ib
- Expected survival time of at least 3 months
- Locally advanced or metastatic solid tumors confirmed by pathology and/or cytology
- Failed standard treatment or unable to receive standard treatment
- Consent to provide tumor tissue samples from primary or metastatic lesions within 3 years
- At least one measurable lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Toxicity from previous cancer treatments returned to grade 1 or below
- No severe cardiac dysfunction; left ventricular ejection fraction at least 50%
- Adequate organ function without recent blood transfusions or stimulating therapies
- Coagulation function: INR and aPTT within 1.5 times the upper normal limit
- Urinary protein level of 2+ or less and under 1000 mg/24 hours
- Premenopausal women must have a negative pregnancy test within 7 days before treatment and not be breastfeeding
- All participants must use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Received chemotherapy, biological, or anti-tumor therapy within 4 weeks or 5 half-lives before first dose; mitomycin or nitrosoureas within 6 weeks; oral drugs like fluorouracil
- History of severe heart disease
- Long QT syndrome, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Other cancers diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two antihypertensive drugs
- Poor blood sugar control
- Grade 2 or higher radiation pneumonitis or current/previous interstitial lung disease
- Severe respiratory impairment due to lung diseases
- Active central nervous system metastasis
- Allergy to recombinant humanized or human-mouse chimeric antibodies or BL-B16D1 components
- Previous organ or allogeneic hematopoietic stem cell transplantation
- Cumulative anthracycline dose over 360 mg/m2 in prior therapy
- Positive for HIV, active tuberculosis, or active hepatitis B or C infection
- Severe infections within 4 weeks or signs of lung infection/inflammation within 2 weeks before treatment
- Large or symptomatic fluid buildup or poorly controlled effusions
- Participation in another clinical trial within 4 weeks before first dose
- Certain eye diseases including active infection, corneal ulcer, monocular vision, corneal transplant history, contact lens dependence, uncontrolled glaucoma, or progressive retinal diseases
- Any other condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 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
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