Actively Recruiting
A Study of BL-B01D1+PD-1 Monoclonal Antibody 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 2025-05-07
46
Participants Needed
1
Research Sites
103 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 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors.
CONDITIONS
Official Title
A Study of BL-B01D1+PD-1 Monoclonal Antibody 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...
- Volunteered to participate and signed informed consent
- Male or female aged 18 to 75 years
- Expected survival time of at least 3 months
- ECOG performance status score of 0 or 1
- Diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) or other solid tumors confirmed by histopathology or cytology
- Provided tumor tissue sample within 3 years for PD-L1 and other testing
- At least one measurable lesion per RECIST v1.1
- No blood transfusion or use of growth factors/platelet-raising drugs within 14 days before screening and meets organ function requirements
- Toxicity from prior antineoplastic therapy resolved to grade 1 or less per NCI-CTCAE v5.0
- Premenopausal women must have negative pregnancy test within 7 days before treatment and not be lactating; all patients must use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Prior treatment with ADC drug containing TOP I inhibitors as toxin
- Antitumor treatment within 4 weeks or five half-lives before first dose; palliative radiotherapy within 2 weeks before first dose
- Received previous systemic antitumor therapy for recurrent/metastatic head and neck squamous cell carcinoma
- Experienced grade 3 or higher immune-related adverse events or grade 2 or higher immune-related myocarditis from immunotherapy
- Use of immunomodulatory drugs or systemic corticosteroids within 14 days or 2 weeks before first dose, respectively
- History of severe cardiovascular or cerebrovascular disease
- Active autoimmune or inflammatory diseases
- Other malignant tumors progressing or treated within 3 years before first dose
- Interstitial lung disease (ILD) requiring steroids, current or suspected ILD at screening
- Poorly controlled diabetes, hypertension, history of hypertensive crisis or encephalopathy
- Unstable thrombotic events needing treatment within 6 months before screening
- Active central nervous system metastasis
- Symptomatic or repeatedly draining pleural, pericardial effusion, or ascites
- Allergic history to recombinant humanized or human-mouse chimeric antibodies or BL-B01D1 excipients
- Prior organ or allogeneic hematopoietic stem cell transplant
- Positive for HIV antibodies, active tuberculosis, or active hepatitis B or C infection
- Active infection requiring systemic therapy
- Participation in another clinical trial within 4 weeks before first dose
- History of psychotropic drug abuse or mental disorders impairing abstinence
- Other conditions deemed inappropriate 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
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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