Actively Recruiting
Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors
Led by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. · Updated on 2025-07-09
80
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
S
Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Lead Sponsor
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to learn if BC008-1A given 900mg or 1200mg intravenously once every 3 weeks is safe and effective to treat patients with advanced esophageal cancer or advanced non-small cell lung cancer. It will also learn about the safety and pharmacokinetics of BC008-1A.
CONDITIONS
Official Title
Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with inoperable, locally advanced or metastatic esophageal squamous cell carcinoma confirmed by histopathology or cytology who have failed standard treatment or have no effective treatment available
- Patients with advanced non-small cell lung cancer (squamous cell carcinoma or adenocarcinoma) confirmed by histology or cytology, with PD-L1 Tumor Proportion Score of 1% or higher, who have failed standard treatment or have no effective treatment available
- Male or female patients aged 18 years or older
- Able to provide informed consent and follow study visit schedules
- Expected survival time of at least 12 weeks
- At least one measurable tumor lesion by CT or MRI, including certain progressing lesions previously treated with radiotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Adequate hematopoietic, liver, kidney, and coagulation function based on specified laboratory tests
- Female patients of childbearing potential and male patients with partners of childbearing potential must use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Prior exposure to any anti-TIGIT drugs
- Participation in another interventional clinical study, except observational studies or survival follow-up stages
- Use of investigational drugs within 4 weeks before study drug administration
- Presence or history of autoimmune diseases or related symptoms
- Receiving anti-tumor treatments within 4 weeks before study drug administration, including chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, or traditional Chinese herbal anti-tumor medicines
- Treatment with corticosteroids or immunosuppressants within 4 weeks before study drug administration
- Receipt of live attenuated vaccines within 4 weeks prior to or planned during the study
- Unresolved toxicities from previous anti-tumor treatments above grade 1, unstable or severe neuropathy, or unresolved immune-related adverse events grade 3 or higher
- History of pneumonia requiring steroids or interstitial lung disease
- Active infections such as bacterial infections, tuberculosis, hepatitis B or C, pulmonary infections
- Known central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal carcinoma
- Positive for certain hepatitis B or C markers, HIV, or syphilis with active infection
- Poorly controlled cardiac conditions, including hypertension, unstable angina, recent myocardial infarction, arrhythmias, or reduced heart function
- History of other cancers within 5 years except certain cured or low-risk cancers
- Allergy to study drug components or related proteins, or history of severe allergic reactions
- History of alcoholism, drug addiction, or abuse within 1 year
- History of neurological or psychiatric disorders affecting compliance
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable 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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jianing Wang
CONTACT
X
Xinlei Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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