|
|
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价BGC515胶囊在晚期实体瘤患者中的安全性、耐受性、药代动力学和初步有效性的I期临床研究
[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 capsules in patients with advanced solid tumors
剂量递增研究:
主要目的:
评估BGC515胶囊在恶性间皮瘤(MM)、上皮样血管内皮细胞瘤(EHE)或其他晚期实体瘤患者中的安全性和耐受性。
探索剂量限制性毒性和最大耐受剂量。
次要目的:
评价BGC515胶囊在MM、EHE或其他晚期实体瘤患者中的药代动力学。
初步评价BGC515胶囊在MM、EHE或其他晚期实体瘤患者中的疗效。
探索性目的:
探索性生物标志物研究。
剂量扩展研究:
主要目的:
进一步评价BGC515胶囊在MM、EHE、胶质母细胞瘤或其他具有NF1/2缺陷、YAP/TAZ融合、LATS1/2突变、MST1/2突变的晚期实体瘤患者中的安全性和耐受性,确定II期推荐剂量。
评价BGC515胶囊在MM、EHE、胶质母细胞瘤或其他具有NF1/2缺陷、YAP/TAZ融合、LATS1/2突变、MST1/2突变的晚期实体瘤患者中的初步有效性。
次要目的:
评价BGC515胶囊在MM、EHE、胶质母细胞瘤或其他具有NF1/2缺陷、YAP/TAZ融合、LATS1/2突变、MST1/2突变的晚期实体瘤患者中的PK。
探索性目的:
探索性生物标志物研究。
[Translation] Dose escalation study:
Primary purpose:
To evaluate the safety and tolerability of BGC515 capsules in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE) or other advanced solid tumors.
To explore dose-limiting toxicity and maximum tolerated dose.
Secondary purpose:
To evaluate the pharmacokinetics of BGC515 capsules in patients with MM, EHE or other advanced solid tumors.
To preliminarily evaluate the efficacy of BGC515 capsules in patients with MM, EHE or other advanced solid tumors.
Exploratory purpose:
Exploratory biomarker study.
Dose expansion study:
Primary purpose:
To further evaluate the safety and tolerability of BGC515 capsules in patients with MM, EHE, glioblastoma or other advanced solid tumors with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation, and determine the recommended dose for Phase II.
To evaluate the preliminary efficacy of BGC515 capsules in patients with MM, EHE, glioblastoma or other advanced solid tumors with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.
Secondary objective:
To evaluate the PK of BGC515 capsules in patients with MM, EHE, glioblastoma or other advanced solid tumors with NF1/2 deficiency, YAP/TAZ fusion, LATS1/2 mutation, MST1/2 mutation.
Exploratory objective:
Exploratory biomarker study.
100 Clinical Results associated with Suzhou Qiaoji Biotechnology Co., Ltd.
0 Patents (Medical) associated with Suzhou Qiaoji Biotechnology Co., Ltd.
100 Deals associated with Suzhou Qiaoji Biotechnology Co., Ltd.
100 Translational Medicine associated with Suzhou Qiaoji Biotechnology Co., Ltd.