Delving into the Latest Updates on BL-M05D1 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Target

CLDN18.2 x Top I

Mechanism

CLDN18.2 inhibitors(Claudin 18.2 inhibitors), TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Locally Advanced Malignant Solid NeoplasmStomach Cancer

Inactive Indication-

Originator Organization

Systimmune, Inc.Startup

Active Organization

Systimmune, Inc.Startup

Sichuan Baili Pharmaceuticals Co.,Ltd

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure/Sequence

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1. 剂量递增阶段（Ia）1）主要目的：观察BL-M05D1在局部晚期或转移性实体瘤患者中的安全性和耐受性，确定 MTD 和 DLT。 2）次要目的：评估BL-M05D1的药代动力学特征和免疫原性。2. 扩大入组阶段（Ib）1）主要目的：进一步观察BL-M05D1在Ia期推荐剂量下的安全性和耐受性，确定 RP2D 。2）次要目的：评估BL-M05D1的初步疗效、药代动力学特征和免疫原性。

[Translation]

1. Dose escalation phase (Ia) 1) Primary objective: To observe the safety and tolerability of BL-M05D1 in patients with locally advanced or metastatic solid tumors, and to determine the MTD and DLT. 2) Secondary objective: To evaluate the pharmacokinetic characteristics and immunogenicity of BL-M05D1. 2. Expansion phase (Ib) 1) Primary objective: To further observe the safety and tolerability of BL-M05D1 at the recommended dose of Phase Ia, and to determine the RP2D. 2) Secondary objective: To evaluate the preliminary efficacy, pharmacokinetic characteristics and immunogenicity of BL-M05D1.

Start Date19 Apr 2024

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

NCT06349811

/ RecruitingPhase 1

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors

This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors.

Start Date19 Apr 2024

Sponsor / Collaborator

Sichuan Baili Pharmaceuticals Co.,Ltd

[+1]

100 Clinical Results associated with BL-M05D1

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100 Translational Medicine associated with BL-M05D1

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100 Patents (Medical) associated with BL-M05D1

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100 Deals associated with BL-M05D1

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Malignant Solid Neoplasm	Phase 1	CN	Sichuan Baili Pharmaceuticals Co.,Ltd	19 Apr 2024
Stomach Cancer	IND Application	US	Systimmune, Inc.Startup	-