Vascular endothelial growth factor receptor x Mitogen-activated protein kinase x Colony stimulating factor 1 receptor x Platelet-derived growth factor receptor x Discoidin domain receptor 1 x C-Raf kinase
Phase I Study on Safety, Tolerance, and Pharmacokinetics of APL-102 Capsule in Patients With Advanced Solid Tumors
This study will evaluate the safety and tolerability of APL-102 Capsule and characterize the pharmacokinetic (PK) profile in advanced solid tumor patients.
[Translation] Phase I clinical study of safety, tolerability and pharmacokinetics of APL-102 capsules in the treatment of patients with advanced solid tumors
Main purposes: 1. To evaluate the safety and tolerability of single and multiple administration of APL-102 capsules; 2. To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Secondary objectives: 1. To study the human pharmacokinetics (PK) characteristics of APL-102 in patients with advanced solid tumors; 2. To evaluate the preliminary antitumor activity of APL-102 capsules in patients with advanced solid tumors. Exploratory purpose: To evaluate the changes of VEGF-A, M-CSF, sVEGFR2 and CD14dim/CD16+ monocytes in the blood of subjects before and after APL-102 treatment, to explore the changes of biomarkers before and after treatment, to explore biomarkers Potential correlation with efficacy of APL-102. Pharmacodynamic targets and potential biomarkers such as CSF1R, CD68, CD163, CD16, DDR1, CD3, CD4, CD8 in tumor tissues were evaluated for their potential association with the efficacy of APL-102.
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