Actively Recruiting
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 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 2025-09-26
186
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II study is designed to investigate the efficacy and safety of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors.
CONDITIONS
Official Title
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 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...
- Participants must voluntarily agree and sign informed consent.
- Men or women aged 18 to 75 years.
- Expected survival of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma confirmed by pathology.
- For certain cohorts, patients must have failed or be intolerant to at least one line of systemic therapy; others may be untreated for recurrent or metastatic disease.
- Willingness to provide archival or fresh tumor tissue samples within the last 3 years.
- At least one measurable tumor lesion according to RECIST v1.1 criteria.
- No blood transfusions or growth factor treatments within 14 days before screening; adequate blood, kidney, liver, and coagulation function.
- Previous treatment side effects must have resolved to grade 1 or less except for some specified non-safety risks.
- Negative pregnancy test for premenopausal women with childbearing potential and use of effective contraception during and 6 months after treatment.
You will not qualify if you...
- Previous treatment with antibody-drug conjugates containing topoisomerase I inhibitors.
- Anticancer treatments (chemotherapy, immunotherapy, radiotherapy, major surgery, targeted therapy) within 4 weeks or 5 half-lives before first dose; some oral drugs or palliative radiotherapy within 2 weeks.
- Non-squamous cell tumor histology.
- Certain cohorts excluded if they have received prior systemic therapy or immunotherapy with severe immune-related adverse events.
- Use of immunomodulatory drugs or systemic corticosteroids above certain doses shortly before study treatment.
- History of severe heart or brain diseases including arrhythmias, infarction, heart failure, stroke within 6 months.
- Active autoimmune or inflammatory diseases requiring systemic treatment.
- Other cancers requiring treatment or progression within 3 years, with some exceptions.
- History or presence of interstitial lung disease or pulmonary inflammation.
- Poorly controlled diabetes, hypertension, or history of hypertensive crisis.
- Recent unstable blood clots or embolism.
- Brain metastases or carcinomatous meningitis unless stable after treatment.
- Symptomatic fluid accumulation requiring drainage.
- Allergy to study drugs or excipients.
- Prior organ or stem cell transplantation.
- Active infections including HIV, tuberculosis, or hepatitis B or C.
- Recent participation in another clinical trial.
- History of drug abuse or mental disorders preventing study compliance.
- Other investigator-determined factors making participation inappropriate.
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
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