Delving into the Latest Updates on HRS-7058 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

HRS-7058

Target

KRAS G12C

Action

inhibitors

Mechanism

KRAS G12C inhibitors(GTPase KRas G12C inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid NeoplasmLocally Advanced Malignant Solid NeoplasmKRAS G12C mutation Solid Tumors

Inactive Indication-

Originator Organization

Shandong Suncadia Medicine Co., Ltd.

Active Organization

Shandong Suncadia Medicine Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs.

Start Date28 Apr 2025

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

CTR20251267

/ RecruitingPhase 2

HRS-7058联合抗肿瘤药物在实体瘤受试者中的安全性、耐受性及有效性的II期临床研究

[Translation] Phase II clinical study on the safety, tolerability and efficacy of HRS-7058 combined with anti-tumor drugs in subjects with solid tumors

主要研究目的：评估HRS-7058联合抗肿瘤药物在实体瘤受试者中的安全性、耐受性，确定II期推荐剂量（RP2D）；评估HRS-7058联合抗肿瘤药物在实体瘤受试者中的客观缓解率。

[Translation]

The main research objectives are to evaluate the safety and tolerability of HRS-7058 combined with anti-tumor drugs in subjects with solid tumors and determine the recommended dose for Phase II (RP2D); to evaluate the objective response rate of HRS-7058 combined with anti-tumor drugs in subjects with solid tumors.

Start Date11 Apr 2025

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

NCT06383871

/ RecruitingPhase 1

An Open, Multicenter Phase I Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-7058 Monotherapy in Patients With Advanced Solid Tumour With KRAS G12C Mutation

This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.

Start Date06 Jun 2024

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

100 Clinical Results associated with HRS-7058

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100 Translational Medicine associated with HRS-7058

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100 Patents (Medical) associated with HRS-7058

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100 Deals associated with HRS-7058

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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	China	Shandong Suncadia Medicine Co., Ltd.	11 Apr 2025
Locally Advanced Malignant Solid Neoplasm	Phase 1	China	Shandong Suncadia Medicine Co., Ltd.	06 Jun 2024
KRAS G12C mutation Solid Tumors	Phase 1	China	Shandong Suncadia Medicine Co., Ltd.	13 May 2024