Actively Recruiting
A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-18
21
Participants Needed
1
Research Sites
104 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, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerance, pharmacokinetic characteristics and preliminary effectiveness of BL-B16D1 in recurrent or metastatic head and neck squamous cell carcinomas and other solid tumors.
CONDITIONS
Official Title
A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness 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
- Pathologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma or other solid tumors after failure or ineligibility for standard treatment
- Agreed to provide archived or fresh tumor tissue samples
- At least one measurable lesion according to RECIST v1.1
- ECOG physical status of 0 or 1
- Toxicity from previous cancer therapy returned to grade 1 or less
- No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
- Adequate organ function without recent blood transfusion or hematopoietic therapy
- Blood coagulation function with INR 1.5 or less and APTT 1.5 times upper limit of normal or less
- Urinary protein level 2+ or less and 1000 mg/24h or less
- For premenopausal women with childbearing potential, negative pregnancy test and not breastfeeding; all patients must use adequate contraception during and for 6 months after treatment
You will not qualify if you...
- Antineoplastic therapy within 4 weeks or 5 half-lives before first dose; Mitomycin and nitrosoureas within 6 weeks; oral fluorouracil
- History of severe heart disease
- QT prolongation, complete left bundle branch block, or third degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Other malignant tumors diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two drugs (systolic >150 mmHg or diastolic >100 mmHg)
- Poor glycemic control
- Grade 1 or higher radiation pneumonitis or history/suspicion of interstitial lung disease
- Severe respiratory impairment from lung diseases
- Active central nervous system symptoms
- Allergy to recombinant humanized or human-mouse chimeric antibodies or BL-B16D1 components
- Prior transplant or allogeneic hematopoietic stem cell transplantation
- Previous anthracycline therapy exceeding 360 mg/m2 cumulative dose
- Positive for HIV, active tuberculosis, or active hepatitis B or C
- Severe infection within 4 weeks or pulmonary infection/inflammation within 2 weeks before first dose
- Massive, symptomatic, 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 retinopathy
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
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
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