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• W4309220900 abstract "Abstract SYHA1813 is a potent, multi-kinase inhibitor that targets vascular endothelial growth factor receptors (VEGFRs)/ colony-stimulating factor 1 receptor (CSF1R). This study aimed to evaluate the safety, pharmacokinetics (PK), and antitumor activity of escalating doses of SYHA1813 in patients with recurrent high-grade gliomas (HGG) or advanced solid tumors. This study adopted a combination of accelerated titration and a 3 + 3 design for dose escalation, with a starting dose of 5 mg once daily. The dose escalation continued at successive dose levels until the maximum-tolerated dose (MTD) was determined. A total of 14 patients were enrolled and treated, including 13 with WHO grade III or IV gliomas, and 1 with colorectal cancer. Two patients experienced dose-limiting toxicities (grade 4 hypertension and grade 3 mucositis oral) at 30 mg SYHA1813. The MTD was defined as 15 mg once daily. Hypertension (n = 6, 42.9%) was the most frequent treatment-related adverse event. Among evaluable patients (n = 10), 2 (20%) patients reached partial response, and 7 (70%) had stable disease. The exposure increased with increasing doses within the studied dose range of 5 to 30 mg. Biomarker assessments demonstrated significant reductions in soluble VEGFR2 ( P = .0023) and increases in VEGFA ( P = .0092) and placental growth factor ( P = .0484). The safety of SYHA1813 was manageable, and encouraging anti-tumor efficacy was observed in patients with recurrent malignant glioma. Chinese Clinical Trial Registry (www.chictr.org.cn/index.aspx), identifier ChiCTR2100045380." @default.
• W4309220900 created "2022-11-24" @default.
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• W4309220900 date "2022-11-15" @default.
• W4309220900 modified "2023-10-18" @default.
• W4309220900 title "A Phase I Dose-Escalation Study of SYHA1813, a VEGFRs and CSF1R Inhibitor, in Patients with Recurrent High-Grade Gliomas or Advanced Solid Tumors" @default.
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• W4309220900 doi "https://doi.org/10.21203/rs.3.rs-2258310/v1" @default.
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