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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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MechanismMDM2-p53 interaction inhibitor |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingEarly Phase 1 A Dose-escalation Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YY2201 in Patients With Advanced Solid Tumors
The goal of this clinical trial is to assess the safety and tolerability of YY2201 in participants with advanced solid tumors. The main questions it aims to answer are:
What medical problems do participants have when taking drug YY2201? What is the maximum tolerated dose (MTD) in patients with advanced solid tumors? What is the anti-tumor efficacy of YY2201 in patients with advanced solid tumors This is a multicenter, open-label, dose-escalation phase I study.
Participants will:
Start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle Perform radiography tumor assessments at screening visit every 2 cycles. Keep a diary of their symptoms.
/ Not yet recruitingPhase 1 一项评估口服YY2201片剂在晚期实体瘤患者中的安全性、耐受性、药代动力学以及初步疗效的I期剂量递增研究
[Translation] A Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral YY2201 Tablets in Patients with Advanced Solid Tumors
主要目的:评估口服 YY2201在晚期实体瘤患者中的安全性和耐受性;评估口服 YY2201在晚期实体瘤患者中的最大耐受剂量(MTD)和/或Ⅱ期推荐剂量(RP2D);
次要目的:评估 YY2201在晚期实体瘤患者中的药代动力学(PK)特征;初步评估口服 YY2201在晚期实体瘤患者中的抗肿瘤疗效。
[Translation] Primary objectives: To evaluate the safety and tolerability of oral YY2201 in patients with advanced solid tumors; To evaluate the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) of oral YY2201 in patients with advanced solid tumors;
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of YY2201 in patients with advanced solid tumors; To preliminarily evaluate the anti-tumor efficacy of oral YY2201 in patients with advanced solid tumors.
100 Clinical Results associated with Jiangsu Yayao Biotech Co., Ltd.
0 Patents (Medical) associated with Jiangsu Yayao Biotech Co., Ltd.
100 Deals associated with Jiangsu Yayao Biotech Co., Ltd.
100 Translational Medicine associated with Jiangsu Yayao Biotech Co., Ltd.