Delving into the Latest Updates on SIM-0500 with Synapse

Overview

Basic Info

Drug Type

Trispecific T-cell engager (TriTE)

Synonyms

GPRC5D-BCMA-CD3, SIM 0500, SIM-0500

Target

BCMA x CD3 x GPRC5D

Mechanism

BCMA inhibitors(B-cell maturation protein inhibitors), CD3 modulators(T cell surface glycoprotein CD3 modulators), GPRC5D modulators(G-protein coupled receptor family C group 5member D modulators)

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [2]

Active Indication

Relapse multiple myelomaMyeloma recurrence

Inactive Indication-

Originator Organization

Simcere Pharmaceutical Group Ltd.

Active Organization

Shanghai Xianxiang Medical Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationFast Track (US)

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This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.

Start Date24 May 2024

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

[+1]

CTR20241358 / RecruitingPhase 1

评价人源化GPRC5D-BCMA-CD3 三特异性抗体 SIM0500在复发或难治性多发性骨髓瘤受试者中的安全性、耐受性、药代动力学和初步抗肿瘤活性的首次人体 (FIH) 、开放性I期研究

[Translation] A first-in-human (FIH), open-label Phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of the humanized GPRC5D-BCMA-CD3 trispecific antibody SIM0500 in subjects with relapsed or refractory multiple myeloma

主要目的： 1、第1部分 (剂量递增) ：评价SIM0500单药治疗的安全性和耐受性，并确定最大耐受剂量 (MTD) 和/或推荐剂量 (RD) 。 2、第2部分 (剂量优化) ：评价SIM0500在拟定RD下的安全性和初步抗肿瘤活性。

[Translation]

Main objectives: 1. Part 1 (dose escalation): Evaluate the safety and tolerability of SIM0500 monotherapy and determine the maximum tolerated dose (MTD) and/or recommended dose (RD). 2. Part 2 (dose optimization): Evaluate the safety and preliminary anti-tumor activity of SIM0500 at the proposed RD.

Start Date08 May 2024

Sponsor / Collaborator

Shanghai Xianxiang Medical Technology Co., Ltd.

100 Clinical Results associated with SIM-0500

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100 Translational Medicine associated with SIM-0500

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100 Patents (Medical) associated with SIM-0500

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100 Deals associated with SIM-0500

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	Phase 1	US	Shanghai Xianxiang Medical Technology Co., Ltd.	24 May 2024
Relapse multiple myeloma	Phase 1	CN	Shanghai Xianxiang Medical Technology Co., Ltd.	24 May 2024
Myeloma recurrence	IND Approval	CN	Shanghai Xianxiang Medical Technology Co., Ltd.	12 Mar 2024