In Vivo |
Simlukafusp alfa (FAP-IL2v) (1 mg/kg; i.v.; weekly for 4 weeks) 在人类癌症小鼠模型中与治疗性抗体联合有效[1]。 Animal Model: huCD16-transgenic SCID mice, lung orthotopic xenograft A549 model[1] Dosage: 1 mg/kg in combination with 25 mg/kg Cetuximab (HY-P9905) as single agents Administration: IV, weekly starting at Day 14 for 4 weeks Result: Achieved greater tumor control than either agent given as monotherapy. Reduced tumor volume and tumor growth. Animal Model: CD-1 mice[1] Dosage: 1, 2 or 4 mg/kg Administration: IV (Pharmacokinetic Analysis) Result: Pharmacokinetic parameters after first dose of human FAP-IL2v (huFAP-IL2v) in CD-1 mice CD-1 mice (n=10 per group) were given 1, 2, and 4 mg/kg huFAP-IL2v by IV administration once weekly. Multiple IV doses at 1 and 2 mg/kg were administered QW for up to a maximum of three doses, at which point toxicity was observed. Only a single dose was administered to the 4-mg/kg IV treatment group because of toxicity in these treatment groups. Blood was sampled at 0.5, 6, 24, 48, 72, and 168 h. huFAP-IL2v dose (mg/kg) Cmax (μg/mL) AUC0-168h (μg•h/mL per mg/kg) CL (mL/d/kg) 1 19.0 557 40.0 2 36.3 479 46.8 4 78.7 541 38.7 AUC0-168h, area under the concentration-time curve from 0 to 168 hours; Cmax, maximum serum concentration observed; CL, total clearance; FAP-IL2v, fibroblast activation protein-α -targeted interleukin 2 variant (IL2v) immunocytokine; hu, humanized; IV, intravenous.
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