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/ Not yet recruitingPhase 1 GKL-006注射液用于不可切除的原发性肝细胞癌(HCC)患者的开放、多次给药的安全性、耐受性和PK/PD的Ib期临床试验
[Translation] An open-label, multiple-dose phase Ib clinical trial to evaluate the safety, tolerability, and PK/PD of GKL-006 injection in patients with unresectable primary hepatocellular carcinoma (HCC)
主要目的:评价GKL-006注射液在不可切除的肝细胞癌患者中多次给药的安全性和耐受性。
次要目的:评价GKL-006注射液多次给药的PK,PD参数。 评价GKL-006注射液多次给药治疗HCC的初步疗效。
[Translation] Primary objective: To evaluate the safety and tolerability of multiple administrations of GKL-006 injection in patients with unresectable hepatocellular carcinoma.
Secondary objective: To evaluate the PK and PD parameters of multiple administrations of GKL-006 injection. To evaluate the preliminary efficacy of multiple administrations of GKL-006 injection in the treatment of HCC.
GKL-006 注射液联合经肝动脉化疗栓塞术(TACE)对比单纯TACE 用于不可切除的肝细胞癌患者中开放、对照单次给药的安全性、耐受性和 PK/PD 的 I 期临床试验
[Translation] Phase I clinical trial of the safety, tolerability and PK/PD of GKL-006 injection combined with transarterial chemoembolization (TACE) versus TACE alone in patients with unresectable hepatocellular carcinoma
评价 GKL-006 注射液联合 TACE 在不可切除的肝细胞癌患者中单次给药的安全性和耐受性,以确定联合方案的最大耐受剂量(MTD),并评价单次给药治疗的剂量限制性毒性(DLT)。
[Translation] To evaluate the safety and tolerability of a single dose of GKL-006 injection combined with TACE in patients with unresectable hepatocellular carcinoma, to determine the maximum tolerated dose (MTD) of the combination regimen, and to evaluate the dose-limiting toxicity (DLT) of single-dose treatment.
An Open Label, Randomized, Controlled, Clinical Trial of Adoptive Autologous Invariant Natural Killer T Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy
The goal of this clinical trial is to explore the efficacy and safety of autologous iNKT cells in patients with progressed hepatocellular carcinoma (HCC) after treatment with PD-1 antibody. The main question it aims to answer are:
the efficacy of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody.
the safety of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody.
Participants will be randomized 1:1 to receive Regorafenib + PD-1 + iNKT cells (RPI group) or the treatment of Regorafenib + PD-1 (RP group).
Researchers will compare RPI group and RP group to see whether the iNKT cells can achieve a better therapeutic effect on HCC patients with PD-1 resistance.
100 Clinical Results associated with Beijing Gene Key Life Technology Co., Ltd
0 Patents (Medical) associated with Beijing Gene Key Life Technology Co., Ltd
100 Deals associated with Beijing Gene Key Life Technology Co., Ltd
100 Translational Medicine associated with Beijing Gene Key Life Technology Co., Ltd