|
|
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
|
MechanismSTAT3 inhibitors |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价YY201在晚期实体瘤和恶性血液肿瘤中的安全性、药代动力学和疗效的多中心、开放I期临床研究
[Translation] A multicenter, open-label Phase I clinical study to evaluate the safety, pharmacokinetics and efficacy of YY201 in advanced solid tumors and hematological malignancies
剂量递增阶段主要目的:评价YY201在晚期实体瘤和复发难治性恶性血液肿瘤患者中的安全性和耐受性,观察可能出现的剂量限制性毒性(DLT)及最大耐受剂量(MTD)和/或 II 期临床试验推荐剂量(RP2D)。次要目的:评价YY201在晚期实体瘤和复发难治性恶性血液肿瘤患者中的药代动力学(PK)特征和初步疗效。探索性目的: 探索生物标志物与疗效之间的关系。 剂量扩展阶段主要目的: 评价YY201在标准治疗失败或无标准治疗的实体瘤(包括三阴性乳腺癌、胰腺癌、头颈部鳞癌等)和复发难治性恶性血液肿瘤(包括急性髓系白血病)以及外周T细胞淋巴瘤患者中的安全性和耐受性,以及初步疗效。次要目的:评价YY201在标准治疗失败或无标准治疗的实体瘤(包括三阴性乳腺癌、胰腺癌、头颈部鳞癌等)和复发难治性恶性血液肿瘤(包括急性髓系白血病)以及外周 T 细胞淋巴瘤患者中的PK特征。探索性目的: 探索生物标志物与疗效之间的关系。
[Translation] The main purpose of the dose escalation phase is to evaluate the safety and tolerability of YY201 in patients with advanced solid tumors and relapsed and refractory hematological malignancies, and to observe possible dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) and/or the recommended dose (RP2D) for Phase II clinical trials. Secondary purpose: to evaluate the pharmacokinetic (PK) characteristics and preliminary efficacy of YY201 in patients with advanced solid tumors and relapsed and refractory hematological malignancies. Exploratory purpose: to explore the relationship between biomarkers and efficacy. The main purpose of the dose expansion phase is to evaluate the safety and tolerability of YY201, as well as the preliminary efficacy, in patients with solid tumors (including triple-negative breast cancer, pancreatic cancer, head and neck squamous cell carcinoma, etc.) and relapsed and refractory hematological malignancies (including acute myeloid leukemia) and peripheral T-cell lymphoma who have failed standard treatment or have no standard treatment. Secondary purpose: To evaluate the PK characteristics of YY201 in patients with solid tumors (including triple-negative breast cancer, pancreatic cancer, head and neck squamous cell carcinoma, etc.) and relapsed and refractory hematological malignancies (including acute myeloid leukemia) and peripheral T-cell lymphoma who have failed or have no standard treatment. Exploratory purpose: To explore the relationship between biomarkers and efficacy.
An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of YY201 in Patients With Advanced Solid Tumors and Hematological Malignancies
This is a multicenter, open-label, phase I clinical study of YY201 in the patients with relapsed/refractory lymphomas and relapsed/refractory large granular lymphocytic leukemia who failed or cannot tolerate standard treatment.
评价YY001治疗晚期实体瘤患者的安全性、耐受性、药代动力学特征的开放性I期临床研究
[Translation] An open-label phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of YY001 in the treatment of patients with advanced solid tumors
主要目的:评价YY001治疗晚期实体瘤患者的安全性、耐受性,观察可能出现的剂量限制性毒性(DLT)及最大耐受剂量(MTD)或推荐II期临床给药剂量(RP2D)。
次要目的:评价YY001在晚期实体瘤患者中的药代动力学(PK)特征和抗肿瘤活性。
探索性目的:初步评价生物标志物与疗效之间的关系。
[Translation] Primary objective: To evaluate the safety and tolerability of YY001 in the treatment of patients with advanced solid tumors, and to observe possible dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) or recommended phase II clinical dose (RP2D).
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics and antitumor activity of YY001 in patients with advanced solid tumors.
Exploratory objective: To preliminarily evaluate the relationship between biomarkers and efficacy.
100 Clinical Results associated with Shanghai Yuyao Biotechnology Co., Ltd.
0 Patents (Medical) associated with Shanghai Yuyao Biotechnology Co., Ltd.
100 Deals associated with Shanghai Yuyao Biotechnology Co., Ltd.
100 Translational Medicine associated with Shanghai Yuyao Biotechnology Co., Ltd.