Delving into the Latest Updates on HC0301 with Synapse

Overview

Basic Info

Drug Type

ASO

Synonyms

Target

Akt-1

Mechanism

Akt-1 inhibitors(Serine/threonine-protein kinase AKT inhibitors)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Advanced Hepatocellular CarcinomaAdvanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Zhejiang Haichang Bio-Tech Co., Ltd.

Active Organization

Zhejiang Haichang Bio-Tech Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (US)

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Structure

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第一阶段目的：主要目的：确定WGI-0301单药治疗晚期末线HCC的MTD/RP2D；次要目的：1.评估WGI-0301在中国人群的血液中的PK特征，2.评估WGI-0301单药在中国人群的安全性和耐受性。第二阶段目的：主要目的：确定WGI-0301联合索拉非尼治疗晚期HCC的MTD/RP2D；次要目的：1.评估WGI-0301和索拉非尼的PK特征，2.评估WGI-0301联合索拉非尼的各个剂量组的安全性和耐受。第三阶段目的：主要目的：采用研究者根据RECIST 1.1评定的ORR指标来评估WGI-0301联合索拉非尼作为晚期HCC二线治疗的有效性；次要目的：1.评估WGI-0301联合索拉非尼的各个剂量组的安全性和耐受性，2.采用研究者根据改良RECIST（Modified Response Evaluation Criteria in Solid Tumors，mRECIST）和RECIST 1.1评定的其他疗效指标来评估WGI-0301联合索拉非尼作为二线治疗晚期HCC的疗效。

[Translation]

Phase I Objectives: Primary Objective: Determine the MTD/RP2D of WGI-0301 monotherapy for advanced end-line HCC; Secondary Objectives: 1. Evaluate the PK characteristics of WGI-0301 in the blood of the Chinese population, 2. Evaluate the safety and tolerability of WGI-0301 monotherapy in the Chinese population. Phase II Objectives: Primary Objective: Determine the MTD/RP2D of WGI-0301 combined with sorafenib for the treatment of advanced HCC; Secondary Objectives: 1. Evaluate the PK characteristics of WGI-0301 and sorafenib, 2. Evaluate the safety and tolerability of each dose group of WGI-0301 combined with sorafenib. Objectives of Phase III: Primary objective: To evaluate the effectiveness of WGI-0301 combined with sorafenib as a second-line treatment for advanced HCC using the ORR indicator assessed by researchers based on RECIST 1.1; Secondary objectives: 1. To evaluate the safety and tolerability of each dose group of WGI-0301 combined with sorafenib, 2. To evaluate the efficacy of WGI-0301 combined with sorafenib as a second-line treatment for advanced HCC using other efficacy indicators assessed by researchers based on modified RECIST (Modified Response Evaluation Criteria in Solid Tumors, mRECIST) and RECIST 1.1.

Start Date-

Sponsor / Collaborator

Zhejiang Haichang Bio-Tech Co., Ltd.

NCT06309485 / Not yet recruitingPhase 2

An Open-Label Phase 2 Study of WGI-0301 Plus Sorafenib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy

The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.

Start Date01 Aug 2024

Sponsor / Collaborator

Zhejiang Haichang Bio-Tech Co., Ltd.

NCT05267899 / RecruitingPhase 1

A Phase I, First in Human, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301, a Lipid Nanoparticle Suspension of Akt-1 Antisense Oligonucleotide, in Patients With Advanced Solid Tumors

The purpose of this study is to learn about the effects of a study medicine, WGI-0301 to find the best dose for treating solid tumors, and to see how safe and tolerable the study drug is for patients with solid tumors.
The study is also done to learn how the study drug is taken up by your body; this is called Pharmacokinetic (PK) studies and how the study drug affects the body; this is called Pharmacodynamics (PD)

Start Date01 Aug 2022

Sponsor / Collaborator

Zhejiang Haichang Bio-Tech Co., Ltd.

100 Clinical Results associated with HC0301

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100 Translational Medicine associated with HC0301

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100 Patents (Medical) associated with HC0301

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3

Literatures (Medical) associated with HC0301

30 Mar 2021·ACS OmegaQ3 · CHEMISTRY

Permanganometric Titration for the Quantification of Purified Bis(2,4,4-trimethylpentyl)dithiophosphinic Acid inn-Dodecane

Q3 · CHEMISTRY

ArticleOA

Author: Bertelsen, Erin R. ; Shafer, Jenifer C. ; Bessen, Nathan P.

The organic soluble extractant bis(2,4,4-trimethylpentyl)dithiophosphinic acid, often called Cyanex 301 (HC301), has shown selectivity for preferentially extracting trivalent actinides over the lanthanides in the treatment of used nuclear fuel. To maintain control and efficiency of a separation process using this extractant, it is necessary to accurately know specific parameters of the system, including the concentration of HC301 in the organic phase, at any given time. Here, the ability to quickly determine the concentration of HC301 in n-dodecane was tested by a one-step permanganometric titration in an organic solution using a double-beam UV-vis spectrophotometer. The addition of HC301 in n-dodecane to solutions of KMnO₄ was found to decolorize the KMnO₄ solutions, but the HC301 was best quantified in terms of decolorization in acetone. This decolorization allowed for the creation of a linear analytical curve relating the amount of KMnO₄ consumed to the amount of HC301 added. Cross-validation of this analytical curve reproduced the known amount of HC301 with an average difference of 1.73% and a maximum of 4.03%.

Dalton TransactionsQ2 · CHEMISTRY

Formation of W/O microemulsions in the extraction of Nd(iii) by bis(2,4,4-trimethylpentyl)dithiophosphinic acid and its effects on Nd(iii) coordination

Q2 · CHEMISTRY

Article

Author: Sun, Taoxiang ; Chen, Jing ; Xu, Chao

Our work describes the formation of W/O microemulsions and its effect on the coordination environment of Nd(iii) in the extraction using purified Cyanex 301 as an extractant.

Physical Chemistry Chemical PhysicsQ2 · CHEMISTRY

Accurate quantum chemical modelling of the separation of Eu³⁺from Am³⁺/Cm³⁺by liquid–liquid extraction with Cyanex272

Q2 · CHEMISTRY

Article

Author: Weissmann, Daniel ; Zhang, Jun ; Chen, Xuebo ; Cao, Xiaoyan ; Dolg, Michael

The liquid–liquid extraction of Eu(iii) with Cyanex272 from aqueous solutions containing Eu(iii), Am(iii) and Cm(iii) is modeled with quantum chemical methods.

100 Deals associated with HC0301

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Hepatocellular Carcinoma	Phase 2	CN	Zhejiang Haichang Bio-Tech Co., Ltd.	05 Jul 2024
Advanced Malignant Solid Neoplasm	Phase 1	US	Zhejiang Haichang Bio-Tech Co., Ltd.	01 Aug 2022
Hepatocellular Carcinoma	Preclinical	US	Zhejiang Haichang Bio-Tech Co., Ltd.	24 Apr 2021