[Translation] Single-arm, open label, single/multiple dose escalation and dose expansion Phase I to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RG002 tablets in patients with advanced solid tumors clinical research
主要研究目的: 剂量递增阶段:
1) 评价RG002片在晚期实体瘤患者中的安全性和耐受性;
2) 确定RG002片的最大耐受剂量(MTD);
3) 确定RG002片的II期临床研究推荐剂量(RP2D); 剂量扩展阶段:
评价RG002片在伴有FGF/FGFR基因改变的晚期实体瘤患者中的抗肿瘤疗效;
次要研究目的: 剂量递增阶段:
1) 评价RG002片在晚期实体瘤患者中的药代动力学及血清磷药效动力学特征;
2) 初步评价RG002片在晚期实体瘤患者中的抗肿瘤疗效; 剂量扩展阶段:
1) 评价RG002片在伴有FGF/FGFR基因改变的晚期实体瘤患者中的血清磷药效动力学特征;
2) 评价RG002片在伴有FGF/FGFR基因改变的晚期实体瘤患者中的安全性和耐受性;
探索性研究目的:
探索FGF/FGFR的基因改变与疗效的相关性。
[Translation] Main study objectives: Dose escalation phase:
1) To evaluate the safety and tolerability of RG002 tablets in patients with advanced solid tumors;
2) Determine the maximum tolerated dose (MTD) of RG002 tablets;
3) Determine the recommended dose (RP2D) for phase II clinical study of RG002 tablets; dose expansion phase:
To evaluate the anti-tumor efficacy of RG002 tablets in patients with advanced solid tumors with FGF/FGFR gene alterations;
Secondary Study Objectives: Dose Escalation Phase:
1) Evaluate the pharmacokinetics and serum phosphorus pharmacodynamic characteristics of RG002 tablets in patients with advanced solid tumors;
2) Preliminary evaluation of the anti-tumor efficacy of RG002 tablets in patients with advanced solid tumors; dose expansion stage:
1) Evaluate the serum phosphorus pharmacodynamic characteristics of RG002 tablets in patients with advanced solid tumors with FGF/FGFR gene alterations;
2) To evaluate the safety and tolerability of RG002 tablets in patients with advanced solid tumors with FGF/FGFR gene alterations;
Purpose of exploratory research:
To explore the correlation between genetic changes of FGF/FGFR and curative effect.