Delving into the Latest Updates on GH-2616 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

GH2616

Target

KIF18A

Mechanism

KIF18A inhibitors(kinesin family member 18A inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid NeoplasmNeoplasms

Inactive Indication-

Originator Organization

Qinhao Pharmaceutical (Suzhou) Co., Ltd.

Active Organization

Qinhao Pharmaceutical (Suzhou) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).

Start Date20 Mar 2024

Sponsor / Collaborator

Henan Cancer Hospital

[+3]

CTR20240250

/ RecruitingPhase 1

评价GH2616片在晚期实体瘤受试者中的安全性、耐受性、药代动力学、药效动力学和初步疗效的剂量递增、剂量扩展的的 Ia/Ib 期临床研究

[Translation] A Phase Ia/Ib dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of GH2616 tablets in subjects with advanced solid tumors

剂量递增阶段（Ia期）：评估GH2616片在晚期实体瘤中的安全性、耐受性和剂量限制性毒性（DLTs）；确定GH2616片治疗晚期实体瘤的最大耐受剂量（MTD）和/或扩展期推荐剂量（RDEs）。剂量拓展阶段（Ib期）：评估GH2616片在晚期实体瘤中的初步抗肿瘤活性和安全性；确定GH2616片II期临床研究推荐剂量（RP2D）。

[Translation]

Dose escalation phase (Phase Ia): Evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of GH2616 tablets in advanced solid tumors; determine the maximum tolerated dose (MTD) and/or recommended doses for extension (RDEs) of GH2616 tablets in the treatment of advanced solid tumors. Dose expansion phase (Phase Ib): Evaluate the preliminary anti-tumor activity and safety of GH2616 tablets in advanced solid tumors; determine the recommended dose (RP2D) of GH2616 tablets in Phase II clinical studies.

Start Date13 Mar 2024

Sponsor / Collaborator

Qinhao Pharmaceutical (Suzhou) Co., Ltd.

CTR20244914

/ Not yet recruitingPhase 1

一项评价GH2616片在晚期实体瘤受试者中的安全性、耐受性、药代动力学和初步疗效的I期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of GH2616 tablets in subjects with advanced solid tumors

剂量递增研究（Ia）主要目的：1、评估GH2616片在具有TP53功能性缺失突变晚期实体瘤中的安全性、耐受性和剂量限制性毒性（DLTs）。2、确定GH2616片治疗晚期实体瘤的最大耐受剂量（MTD）和/或扩展期推荐剂量（RDEs）。剂量扩展研究（Ib）主要目的：1、评估GH2616片在具有TP53功能性缺失突变和WGD特征的晚期实体瘤受试者中的初步抗肿瘤活性和安全性。2、确定GH2616片II期临床研究推荐剂量（RP2D）。

[Translation]

Dose escalation study (Ia) Main objectives: 1. Evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of GH2616 tablets in advanced solid tumors with TP53 functional loss mutations. 2. Determine the maximum tolerated dose (MTD) and/or recommended doses (RDEs) for the extension period of GH2616 tablets for the treatment of advanced solid tumors. Dose expansion study (Ib) Main objectives: 1. Evaluate the preliminary anti-tumor activity and safety of GH2616 tablets in subjects with advanced solid tumors with TP53 functional loss mutations and WGD characteristics. 2. Determine the recommended dose (RP2D) for the Phase II clinical study of GH2616 tablets.

Start Date-

Sponsor / Collaborator

Qinhao Pharmaceutical (Suzhou) Co., Ltd.

100 Clinical Results associated with GH-2616

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100 Translational Medicine associated with GH-2616

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100 Patents (Medical) associated with GH-2616

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100 Deals associated with GH-2616

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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	CN	Qinhao Pharmaceutical (Suzhou) Co., Ltd.	13 Mar 2024
Neoplasms	IND Application	US	Qinhao Pharmaceutical (Suzhou) Co., Ltd.	11 Jan 2024