OncoMatch/Clinical Trials/NCT05262491
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
Is NCT05262491 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-B01D1 for gastrointestinal tumor.
Treatment: BL-B01D1 — In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
failing standard therapy, or who are not eligible for standard therapy at this stage
Cannot have received: ADC targeting TROP2
Prior treatment with ADC drugs targeting TROP2
Cannot have received: ADC using camptothecin derivatives (topoisomerase I inhibitors) as toxins
ADC drugs using camptothecin derivatives (topoisomerase I inhibitors) as toxins
Cannot have received: chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy
Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: mitomycin (mitomycin)
mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
Cannot have received: nitrosoureas (nitrosoureas)
mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
Cannot have received: oral fluorouracil-like drugs (S-1, capecitabine)
oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration
Cannot have received: palliative radiotherapy
oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration
Cannot have received: anthracycline
Exception: cumulative dose > 360 mg/m2
In previous adjuvant therapy with anthracyclines, the cumulative dose of anthracyclines was > 360 mg/m2
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, Platelet count ≥90×10^9/L, Hemoglobin ≥90 g/L
Kidney function
Creatinine ≤1.5 ULN, or creatinine clearance ≥50 mL/min
Liver function
Total bilirubin ≤1.5 ULN, AST and ALT ≤2.5 ULN for participants without liver metastasis, AST and ALT ≤5.0 ULN for liver metastases
Has adequate organ function before registration, defined as: a) Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count ≥90×109/L, Hemoglobin ≥90 g/L; B) Hepatic function: Total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN for participants without liver metastasis, AST and ALT ≤5.0 ULN for liver metastases; c) Renal function: Creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to the Cockcroft and Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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