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Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

HS-20105

Target

Trop-2

Action

modulators

Mechanism

Trop-2 modulators(Tumor-associated calcium signal transducer 2 modulators)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Changzhou Hansoh Pharmaceutical Co., Ltd.

Shanghai Hansoh Biomedical Co. Ltd.

Active Organization

Shanghai Hansoh Biomedical Co. Ltd.

Inactive Organization

Changzhou Hansoh Pharmaceutical Co., Ltd.

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Structure/Sequence

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HS-20105 is a novel antibody-drug conjugate (ADC) targeting Trop-2. This first-in-human trial is aimed to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics (PK), safety and preliminary anti-tumor activity of HS-20105 in patients with advanced solid tumors.

Start Date01 Mar 2024

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

CTR20233661

/ TerminatedPhase 1

注射用HS-20105在晚期实体瘤受试者中的安全性、耐受性、药代动力学和有效性的I期临床研究

[Translation] A Phase I clinical study of the safety, tolerability, pharmacokinetics and efficacy of HS-20105 for injection in subjects with advanced solid tumors

主要研究目的：评价HS-20105在晚期实体瘤受试者中的安全性和耐受性。次要研究目的：1.评价HS-20105在晚期实体瘤受试者中的PK特征；2. 评价HS-20105在晚期实体瘤受试者中的有效性；3.评价HS-20105在晚期实体瘤受试者中的免疫原性。探索性研究目的：1.探索HS-20105暴露量与效应之间的关系；2.探索基线肿瘤组织Trop-2蛋白表达与HS-20105有效性之间的关系。

[Translation]

Primary study objectives: To evaluate the safety and tolerability of HS-20105 in subjects with advanced solid tumors. Secondary study objectives: 1. To evaluate the PK characteristics of HS-20105 in subjects with advanced solid tumors; 2. To evaluate the efficacy of HS-20105 in subjects with advanced solid tumors; 3. To evaluate the immunogenicity of HS-20105 in subjects with advanced solid tumors. Exploratory study objectives: 1. To explore the relationship between HS-20105 exposure and effect; 2. To explore the relationship between baseline tumor tissue Trop-2 protein expression and HS-20105 efficacy.

Start Date10 Jan 2024

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

[+1]

100 Clinical Results associated with HS-20105

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100 Translational Medicine associated with HS-20105

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100 Patents (Medical) associated with HS-20105

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100 Deals associated with HS-20105

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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 2	-	Shanghai Hansoh Biomedical Co. Ltd.	01 Mar 2024

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Clinical Result

Indication

Phase

Evaluation

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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