Delving into the Latest Updates on TGRX-678 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

TGRX 678, TGRX678

Target

Bcr-Abl T315I

Mechanism

Bcr-Abl T315I inhibitors(BCR-ABL T315I mutation inhibitors)

Therapeutic Areas

NeoplasmsHemic and Lymphatic Diseases

Active Indication

Aggressive-Phase Chronic Myelocytic LeukemiaPhiladelphia chromosome positive chronic myelogenous leukemiarefractory chronic myelocytic leukemia

Inactive Indication-

Originator Organization

Shenzhen TargetRx, Inc.Startup

Active Organization

Shenzhen TargetRx, Inc.Startup

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationBreakthrough Therapy (CN)

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主要研究目的：评价健康受试者在空腹、进食低脂餐和进食高脂餐状态下，单次口服TGRX-678片后TGRX-678的药代动力学特征以及食物对TGRX-678药代动力学的影响。次要研究目的：评价健康受试者在空腹、进食低脂餐和进食高脂餐状态下，单次口服TGRX-678片的安全性和耐受性。

[Translation]

Primary study objective: To evaluate the pharmacokinetic characteristics of TGRX-678 after a single oral administration of TGRX-678 tablets in healthy subjects in the fasting, low-fat meal and high-fat meal states, as well as the effect of food on the pharmacokinetics of TGRX-678. Secondary study objective: To evaluate the safety and tolerability of a single oral administration of TGRX-678 tablets in healthy subjects in the fasting, low-fat meal and high-fat meal states.

Start Date21 Nov 2024

Sponsor / Collaborator

Shenzhen TargetRx, Inc.Startup

NCT06697899 / Not yet recruitingPhase 1

Food Effect on Pharmacokinetic Profile for TGRX-678 Tablet in Chinese Healthy Subject With Single Oral Administration

A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-678

Start Date20 Nov 2024

Sponsor / Collaborator

Shenzhen TargetRx, Inc.Startup

[+1]

NCT06088888 / RecruitingPhase 1

A Single-arm, Open-label, Dose Escalation + Cohort Expansion Phase 1 Trial on Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Subjects With Refractory or Advanced Chronic Myelogenous Leukemia

The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.

Start Date15 Jun 2024

Sponsor / Collaborator

Shenzhen TargetRx, Inc.Startup

[+1]

100 Clinical Results associated with TGRX-678

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100 Translational Medicine associated with TGRX-678

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100 Patents (Medical) associated with TGRX-678

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100 Deals associated with TGRX-678

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aggressive-Phase Chronic Myelocytic Leukemia	Phase 2	CN	Shenzhen TargetRx, Inc.Startup	05 Jun 2024
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 1	CN	Shenzhen TargetRx, Inc.Startup	29 Mar 2021
refractory chronic myelocytic leukemia	Phase 1	CN	Shenzhen TargetRx, Inc.Startup	29 Mar 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	-	-	TGRX-678	pevhmoxfzz(zmcyguyxct) = jgqnbnrcpy pvvgvkydvj (nbzdxzvudk ) View more	-	08 Dec 2024
ASH2023	Phase 1	refractory chronic myelocytic leukemia	95	TGRX-678	hepykcokol(bvoqwywndz) = aolkjkqajp zraqfjeatd (mpkesbimbr ) View more	-	11 Dec 2023