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]

NCT06652997

/ CompletedPhase 1IIT

SPH3348 Tablets in a Single-center, Randomized, Open-label, Single-dose, Two-period, Two-sequence Crossover Design Food Effect Study in Healthy Chinese Subjects

The goal of this clinical trial is to evaluate the pharmacokinetic (PK) characteristics of single oral doses of SPH3348 tablets in healthy subjects under fasting and fed conditions, as well as the impact of food on PK.

Start Date15 Jul 2022

Sponsor / Collaborator

West China Second Hospital of Sichuan University

[+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