ALK inhibitors(Anaplastic lymphoma kinase inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors), RTK inhibitors(Receptor protein-tyrosine kinase inhibitors)

Therapeutic Areas

Neoplasms

Active Indication-

Inactive Indication

ALK fusion Positive Solid TumorsLocally Advanced Malignant Solid NeoplasmNTRK fusion-positive solid tumors+ [2]

Originator Organization

Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.

Active Organization-

Inactive Organization

Jiangsu Simcere Pharmaceutical Co., Ltd.

Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.

Simcere Pharmaceutical Group Ltd.

Drug Highest PhaseDiscontinuedPhase 1

First Approval Date-

Regulation-

Clinical Trials associated with SIM-1803-1A

NCT04671849 / Unknown statusPhase 1

An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.

This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. The cancer must have a change in a particular gene (NTRK1, NTRK2, NTRK3, ROS1 or ALK). SIM1803-1A is a drug that blocks the actions of these NTRK/ ROS1 /ALK genes in cancer cells and can therefore be used to treat cancer.

Start Date21 Dec 2020

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

CTR20202292 / TerminatedPhase 1

评价SIM1803-1A 在NTRK、ROS1 或ALK 基因融合突变的局部晚期/转移性实体瘤患者中的安全性、有效性及药代动力学特征的开放、多中心、I 期临床研究

[Translation] An open, multicenter, Phase I clinical study to evaluate the safety, efficacy, and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1, or ALK gene fusion mutations

Ia期-主要目的：评价SIM1803-1A 的安全性和耐受性；评价SIM1803-1A 的药代动力学特征；确定SIM1803-1A 的最大耐受剂量（MTD）和后续研究的合适推荐剂量（RD）。次要目的：初步评价SIM1803-1A 治疗NTRK、ROS1 或ALK 基因融合突变的局部晚期/转移性实体瘤患者的有效性。 Ib期-主要目的：评价SIM1803-1A 治疗NTRK、ROS1 或ALK 基因融合突变的局部晚期/转移性实体瘤患者的有效性。次要目的：评价SIM1803-1A 治疗NTRK、ROS1 或ALK 基因融合突变的局部晚期/转移性实体瘤患者的安全性；评价Ⅰa 期推荐剂量下SIM1803-1A 的药代动力学特征。

[Translation]

Phase Ia-Primary purpose: To evaluate the safety and tolerability of SIM1803-1A; To evaluate the pharmacokinetic characteristics of SIM1803-1A; To determine the maximum tolerated dose (MTD) of SIM1803-1A and the appropriate recommended dose (RD) for subsequent studies. Secondary purpose: To preliminarily evaluate the effectiveness of SIM1803-1A in treating patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. Phase Ib-Primary purpose: To evaluate the effectiveness of SIM1803-1A in treating patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. Secondary purpose: To evaluate the safety of SIM1803-1A in treating patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations; To evaluate the pharmacokinetic characteristics of SIM1803-1A at the recommended dose of Phase Ia.

Start Date21 Dec 2020

Sponsor / Collaborator

Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.

100 Clinical Results associated with SIM-1803-1A

100 Translational Medicine associated with SIM-1803-1A

100 Patents (Medical) associated with SIM-1803-1A

100 Deals associated with SIM-1803-1A

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ALK fusion Positive Solid Tumors	Phase 1	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	21 Dec 2020
Locally Advanced Malignant Solid Neoplasm	Phase 1	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	21 Dec 2020
NTRK fusion-positive solid tumors	Phase 1	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	21 Dec 2020
ROS1 positive Solid Tumors	Phase 1	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	21 Dec 2020
Solid tumor	Phase 1	CN	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	21 Dec 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SIM1803-1A (CSCO2022)	Not Applicable	ROS1 positive Solid Tumors \| ALK fusion Positive Solid Tumors \| NTRK fusion-positive solid tumors	22	SIM1803-1A	idvruwubml(pojrlpbhwv) = 丙氨酸氨基转移酶升高(22.7%) zdyqvedaus (wljhjdfrzt ) View more	-	21 Sep 2022

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