Delving into the Latest Updates on HYP-2090PTSA with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HY 0002, HY-0002, HY-0002a

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Target

Class I PI3K x KRAS G12C

Mechanism

Class I PI3K inhibitors(PI3-kinase class I inhibitors), KRAS G12C inhibitors(GTPase KRas G12C inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid NeoplasmKRAS G12C mutation Solid Tumors

Inactive Indication-

Originator Organization

Sichuan Huiyu Pharmaceutical Co., Ltd.

Active Organization

Sichuan Huiyu Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

Start Date04 Feb 2024

Sponsor / Collaborator

Sichuan Huiyu Pharmaceutical Co., Ltd.

CTR20234061 / Not yet recruitingPhase 1/2

一项评估HYP-2090PTSA在KRAS突变的晚期实体瘤患者中的安全性、耐受性、药代动力学和有效性的开放性、多中心、多队列的I/II期研究

[Translation] An open-label, multicenter, multi-cohort Phase I/II study evaluating the safety, tolerability, pharmacokinetics, and efficacy of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutations

剂量递增主要目的：评价HYP-2090PTSA在KRAS突变的晚期实体瘤患者中的安全性和耐受性；确定HYP-2090PTSA推荐II期剂量（RP2D）和/或最大耐受剂量（MTD）。剂量扩展主要目的：评价HYP-2090PTSA在KRAS G12C突变的晚期实体瘤患者中的有效性。

[Translation]

Dose escalation: Primary objective: To evaluate the safety and tolerability of HYP-2090PTSA in patients with advanced solid tumors with KRAS mutations; To determine the recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD) of HYP-2090PTSA. Dose expansion: Primary objective: To evaluate the efficacy of HYP-2090PTSA in patients with advanced solid tumors with KRAS G12C mutations.

Start Date-

Sponsor / Collaborator

Sichuan Huiyu Seacross Pharma Technology Ltd.

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100 Clinical Results associated with HYP-2090PTSA

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100 Translational Medicine associated with HYP-2090PTSA

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100 Patents (Medical) associated with HYP-2090PTSA

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100 Deals associated with HYP-2090PTSA

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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 2	CN	Sichuan Huiyu Pharmaceutical Co., Ltd.	04 Feb 2024
KRAS G12C mutation Solid Tumors	Phase 2	CN	Sichuan Huiyu Pharmaceutical Co., Ltd.	22 Dec 2023
Solid tumor	Preclinical	EU	Sichuan Huiyu Pharmaceutical Co., Ltd.	18 Oct 2021