Delving into the Latest Updates on Xadcera Biopharmaceutical (Suzhou) Co., Ltd. with Synapse

Overview

Tags

Neoplasms

Respiratory Diseases

Digestive System Disorders

Antibody drug conjugate (ADC)

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	2

Top 5 Drug Type	Count

Antibody drug conjugate (ADC)	2

Top 5 Target	Count

HER3 x MUC1	1
EGFR x Trop-2	1

主要目的第1部分（剂量递增） o评估 DM001 的安全性和耐受性 o确定扩展部分的推荐剂量(RDE) 第2部分（剂量扩展） o评估 DM001 的安全性和耐受性 o评价 DM001 的抗肿瘤活性次要目的第1部分（剂量递增） o评估 DM001 的药代动力学 (PK) 特征 o评价 DM001 的抗肿瘤活性 o评估 DM001 的免疫原性第2部分（剂量扩展） o评估 DM001 的 PK 特征 o进一步评价 DM001 的抗肿瘤活性 o评估 DM001 的免疫原性探索性目的探索与 DM001 抗肿瘤活性相关的生物标志物（滋养层细胞表面抗原 2[TROP2] 和/或表皮生长因子受体 [EGFR]）

[Translation]

Primary Objectives Part 1 (Dose Escalation) o Evaluate the safety and tolerability of DM001 o Determine the recommended dose (RDE) for the expansion part Part 2 (Dose Expansion) o Evaluate the safety and tolerability of DM001 o Evaluate the anti-tumor activity of DM001 Secondary Objectives Part 1 (Dose Escalation) o Evaluate the pharmacokinetic (PK) characteristics of DM001 o Evaluate the anti-tumor activity of DM001 o Evaluate the immunogenicity of DM001 Part 2 (Dose Expansion) o Evaluate the PK characteristics of DM001 o Further evaluate the anti-tumor activity of DM001 o Evaluate the immunogenicity of DM001 Exploratory Objectives Explore biomarkers (trophoblast cell surface antigen 2 [TROP2] and/or epidermal growth factor receptor [EGFR]) associated with the anti-tumor activity of DM001

Start Date-

Sponsor / Collaborator

Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

NCT06475937 / RecruitingPhase 1

A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors.
Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.

Start Date22 Oct 2024

Sponsor / Collaborator

Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

100 Clinical Results associated with Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

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0 Patents (Medical) associated with Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

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100 Deals associated with Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

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100 Translational Medicine associated with Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 27 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

1

Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

DM001 ( EGFR x Trop-2 )	Hormone receptor positive HER2 negative breast cancer More	Phase 1
DM-002 (Xadcera Biopharma) ( HER3 x MUC1 )	Neoplasms More	Discovery