OncoMatch/Clinical Trials/NCT05194982
A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor
Is NCT05194982 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-B01D1 for locally advanced or metastatic solid tumor.
Treatment: BL-B01D1 — In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic 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 solid tumor will be evaluated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Chemotherapy ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: biological therapy
biological therapy ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: immunotherapy
immunotherapy ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: radical radiotherapy
radical radiotherapy ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: major surgery
major surgery ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: targeted therapy
targeted therapy (including small molecule inhibitor of tyrosine kinase) ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: mitomycin (mitomycin)
mitomycin ... within 6 weeks prior to the first administration
Cannot have received: nitrosoureas (nitrosoureas)
nitrosoureas ... 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 ... within 2 weeks prior to the first administration
Cannot have received: palliative radiotherapy
palliative radiotherapy within 2 weeks prior to the first administration
Lab requirements
Blood counts
absolute neutrophilic granulocyte count (ANC) ≥1.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90 g/L
Kidney function
creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula)
Liver function
total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis
Cardiac function
No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%
The organ function level must meet the following requirements: a) bone marrow function: absolute neutrophilic granulocyte count (ANC) ≥1.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90 g/L; b) Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis; c) Kidney function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula). No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify