Delving into the Latest Updates on SPH3348 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

SPH-3348

Target

c-Met

Action

inhibitors

Mechanism

c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Shanghai Pharmaceuticals Holding Co., Ltd.

Active Organization

SPH (Benxi) North Pharmaceutical Co., Ltd.

Shanghai Pharmaceuticals Holding Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationSpecial Review Project (China)

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To evaluate the pharmacokinetic characteristics of a single oral dose of SPH3348 tablets in healthy subjects on an empty stomach and after a meal, and the effect of food on PK. To evaluate the safety and tolerability of a single oral dose of SPH3348 tablets in healthy subjects on an empty stomach and after a meal.

Start Date15 Jul 2022

Sponsor / Collaborator

Shanghai Pharmaceuticals Holding Co., Ltd.

[+1]

CTR20192450

/ CompletedPhase 1

SPH3348片单药及联用奥希替尼治疗中国c-Met异常的晚期实体瘤患者的I期临床试验

[Translation] Phase I clinical trial of SPH3348 tablets alone and in combination with osimertinib in Chinese patients with advanced solid tumors with c-Met abnormalities

1.评价SPH3348片在c-Met异常的晚期实体瘤患者中的安全性和耐受性。 2.评估SPH3348片联用奥希替尼在EGFR突变、EGFR-TKI(1～3代)治疗耐药后，c-Met异常的局部晚期或转移性NSCLC患者中的安全性及耐受性。

[Translation]

1. To evaluate the safety and tolerability of SPH3348 tablets in patients with advanced solid tumors and c-Met abnormalities. 2. To evaluate the safety and tolerability of SPH3348 tablets combined with osimertinib in patients with locally advanced or metastatic NSCLC and c-Met abnormalities after EGFR mutations, resistance to EGFR-TKI (1st to 3rd generation) treatment.

Start Date03 Jun 2020

Sponsor / Collaborator

Shanghai Pharmaceuticals Holding Co., Ltd.

[+1]

100 Clinical Results associated with SPH3348

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100 Translational Medicine associated with SPH3348

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100 Patents (Medical) associated with SPH3348

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100 Deals associated with SPH3348

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	China	SPH (Benxi) North Pharmaceutical Co., Ltd.	03 Jun 2020
Advanced Malignant Solid Neoplasm	Phase 1	China	Shanghai Pharmaceuticals Holding Co., Ltd.	03 Jun 2020