Delving into the Latest Updates on SIM-0508 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

SIM 0508, SIM0508

Target

POLQ

Mechanism

POLQ inhibitors(DNA polymerase theta inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid NeoplasmSolid tumorLocally Advanced Malignant Solid Neoplasm+ [1]

Inactive Indication-

Originator Organization

Simcere Pharmaceutical Group Ltd.

Active Organization

Simcere Pharmaceutical Group Ltd.Shanghai Xianxiang Medical Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：第1a部分-SIM0508单药治疗的剂量递增：评价SIM0508单药治疗的安全性和耐受性，并确定最大耐受剂量（MTD）/最大给药剂量（MAD）/潜在推荐剂量（RD1）（如有）。次要目的：进一步确定SIM0508单药治疗或与奥拉帕利联合治疗的安全性和耐受性。探索性目的：评价SIM0508单药治疗或与奥拉帕利联合治疗的药效学（PD）效应。探索PK与PD、疗效和安全性的潜在相关性。

[Translation]

Primary objective: Part 1a - Dose escalation of SIM0508 monotherapy: Evaluate the safety and tolerability of SIM0508 monotherapy and determine the maximum tolerated dose (MTD)/maximum administered dose (MAD)/potential recommended dose (RD1) (if any). Secondary objective: Further determine the safety and tolerability of SIM0508 monotherapy or in combination with olaparib. Exploratory objective: Evaluate the pharmacodynamic (PD) effect of SIM0508 monotherapy or in combination with olaparib. Explore the potential correlation between PK and PD, efficacy and safety.

Start Date-

Sponsor / Collaborator

Shanghai Xianxiang Medical Technology Co., Ltd.

100 Clinical Results associated with SIM-0508

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100 Translational Medicine associated with SIM-0508

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100 Patents (Medical) associated with SIM-0508

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100 Deals associated with SIM-0508

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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	Shanghai Xianxiang Medical Technology Co., Ltd.	04 Nov 2024
Solid tumor	IND Approval	US	Simcere Pharmaceutical Group Ltd.	29 Aug 2024
Locally Advanced Malignant Solid Neoplasm	IND Approval	CN	Shanghai Xianxiang Medical Technology Co., Ltd.	22 Aug 2024
Metastatic Solid Tumor	IND Approval	CN	Shanghai Xianxiang Medical Technology Co., Ltd.	22 Aug 2024