A Multicenter, Open, Single-arm Phase I Dose Exploration and Phase II Extended Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of FCN-011 in Patients With Advanced Solid Tumor (Phase I) and NTRK Fusion Positive Advanced Solid Tumor (Phase II)
A multicenter, open, single-arm phase I dose exploration and phase II extended study was conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary antitumor activity of FCN-011 in patients with advanced solid tumor (phase I) and NTRK fusion positive advanced solid tumor (phase II)
I 期主要研究目的:(1)观察单次口服和连续口服FCN-011 单药治疗无法手术切除的III期或IV 期晚期实体瘤患者的安全性和耐受性;(2)确定FCN-011 的最大耐受剂量(MTD)和II 期临床研究推荐剂量(RP2D)。
I 期次要研究目的:(1)初步观察口服FCN?011 在晚期实体瘤患者中的抗肿瘤疗效;(2)评价FCN?011 的药物代谢动力学(PK)特征。
II 期主要研究目的:评价连续口服FCN-011 单药在NTRK 融合阳性、无法手术切除的 III 期或IV 期晚期实体瘤患者中的疗效。
II 期次要研究目的:(1)评价连续FCN-011 口服单药在NTRK 融合阳性、无法手术切除的 III 期或IV 期晚期实体瘤患者中的安全性和耐受性;(2)评价FCN-011 的PK 特征(如Ⅰ期研究完成后有必要);(3)初步评价FCN-011 群体药物代谢动力学(PopPK)特征。