OncoMatch/Clinical Trials/NCT06773507
Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors
Is NCT06773507 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BC008-1A 900mg and BC008-1A 1200mg for advanced esophageal cancers.
Treatment: BC008-1A 900mg · BC008-1A 1200mg — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (TPS ≥ 1%)
PD-L1 Tumor Proportion Score (TPS) ≥ 1%
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
failed standard treatment or have no effective standard treatment available
Cannot have received: anti-TIGIT drug
Having been previously exposed to any anti-TIGIT drugs
Cannot have received: investigational drug
Having received any investigational drugs within 4 weeks prior to the first administration of the study drug
Cannot have received: systemic chemotherapy
Exception: oral fluorouracil drugs: 2 weeks; mitomycin C and nitrosourea drugs: 6 weeks
Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: systemic chemotherapy (the washout period for oral fluorouracil drugs is 2 weeks, and that for mitomycin C and nitrosourea drugs is 6 weeks)
Cannot have received: endocrine therapy
Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: endocrine therapy
Cannot have received: targeted therapy
Exception: small molecule targeted therapy: 2 weeks or 5 half-lives, whichever is longer
Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: targeted therapy (the washout period for small molecule targeted therapy is 2 weeks or 5 half-lives, whichever is longer)
Cannot have received: immunotherapy
Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: immunotherapy
Cannot have received: tumor embolization
Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: tumor embolization
Cannot have received: traditional Chinese herbal medicines with anti-tumor indications
Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: ...treatment with traditional Chinese herbal medicines with anti-tumor indications
Lab requirements
Blood counts
Basically normal hematopoietic system: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L, Platelet (PLT) ≥ 90 × 10^9/L, Hemoglobin (Hb) ≥ 90 g/L
Kidney function
Basically normal kidney function: Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
Basically normal liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN (for subjects with liver metastases, Total Bilirubin ≤ 2.5 × ULN), Alanine Transaminase (ALT) ≤ 2.5 × ULN, Aspartate Transaminase (AST) ≤ 2.5 × ULN (for subjects with liver metastases, ALT ≤ 5 × ULN, AST ≤ 5 × ULN), Alkaline Phosphatase ≤ 2.5 × ULN (for subjects with liver or bone metastases, Alkaline Phosphatase ≤ 5 × ULN), Plasma Albumin (ALB) ≥ 28 g/L
Cardiac function
Basically normal coagulation function: INR ≤ 1.5 × ULN or PT ≤ 1.5 × ULN or APTT ≤ 1.5 × ULN (for subjects receiving anticoagulant therapy, the investigator judges that INR, PT and APTT are all within the safe and effective treatment range without clinical conditions of active bleeding or increased bleeding risk)
sufficient hematopoietic, liver and kidney functions and meet the following laboratory test results before enrollment (no use of any cell growth factors, platelet or red blood cell transfusions, etc. within 1 week before the first dose of study treatment): ... Basically normal hematopoietic system: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L, Platelet (PLT) ≥ 90 × 10^9/L, Hemoglobin (Hb) ≥ 90 g/L; Basically normal liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN (for subjects with liver metastases, Total Bilirubin ≤ 2.5 × ULN), Alanine Transaminase (ALT) ≤ 2.5 × ULN, Aspartate Transaminase (AST) ≤ 2.5 × ULN (for subjects with liver metastases, ALT ≤ 5 × ULN, AST ≤ 5 × ULN), Alkaline Phosphatase ≤ 2.5 × ULN (for subjects with liver or bone metastases, Alkaline Phosphatase ≤ 5 × ULN), Plasma Albumin (ALB) ≥ 28 g/L; Basically normal kidney function: Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); Basically normal coagulation function: INR ≤ 1.5 × ULN or Prothrombin Time (PT) ≤ 1.5 × ULN or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (for subjects receiving anticoagulant therapy, the investigator judges that INR, PT and APTT are all within the safe and effective treatment range without clinical conditions of active bleeding or increased bleeding risk).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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