A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor
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.
• Participants must sign the informed consent form voluntarily and follow the plan requirements.
• No gender limit.
• Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib).
• Expected survival time ≥ 3 months.
• Locally advanced or metastatic solid tumor confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment.
• Agrees to provide archived tumor tissue specimens or fresh tissue samples from the primary lesion or metastasis within 2 years; If a subject is unable to provide a tumor tissue sample, he/she may be enrolled after being evaluated by the investigator if other inclusion criteria are met.
• Participants must have at least one measurable lesion that meets the definition of RECIST v1.1.
• Physical fitness score ECOG 0 or 1 point
• Toxicity of previous antitumor therapy has returned to ≤ level 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by the investigators, such as elevated ALP, hyperuricemia, and elevated blood glucose; Toxicities with no safety risk, such as hair loss and grade 2 peripheral neurotoxicity, were excluded. Or decreased hemoglobin except ≥90 g/L).
⁃ 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) ≥1.5×109/L, platelet count ≥90×109/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).
⁃ Coagulation function: International normalized ratio (INR)≤1.5×ULN, and activated partial thromboplastin time (APTT)≤1.5ULN.
⁃ Urinary protein ≤2+ or ≤1000mg/24h.
⁃ For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating; all participants (regardless of male or female) in the group should be treated throughout the treatment. Adequate barrier contraceptive measures should be taken during the treatment and 6 months after the treatment.