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Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

AMT151

Target

FOLR1

Action

antagonists

Mechanism

FOLR1 antagonists(Folate receptor alpha antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [4]

Active Indication

Adenocarcinoma of LungAdvanced Malignant Solid NeoplasmEndometrial Carcinoma+ [13]

Inactive Indication-

Originator Organization

Multitude Therapeutics, Inc.

Active Organization

Multitude Therapeutics, Inc. (China)

Multitude, Inc.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure/Sequence

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This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advanced solid tumors.

Start Date25 Jan 2023

Sponsor / Collaborator

Multitude, Inc.

[+1]

CTR20232237

/ Not yet recruitingPhase 1

AMT-151（一种抗叶酸受体α抗体偶联药物）在选定的晚期实体瘤患者中的首次人体I期研究

[Translation] A first-in-human phase I study of AMT-151, an anti-folate receptor alpha antibody-drug conjugate, in selected patients with advanced solid tumors

主要目的： 1）确定AMT-151的最大耐受剂量（MTD）和推荐II期剂量（RP2D）。 2）评估AMT-151的安全性和耐受性。次要目的： 1）初步评价AMT-151的抗肿瘤活性。 2）评价AMT-151的药代动力学（PK）特征。 3）评价AMT-151的免疫原性。探索性目的： 1）评价AMT-151的药效学（PD）特征。 2）评价叶酸途径血液标志物对FRα表达和AMT-151治疗反应的影响。

[Translation]

Primary objectives: 1) Determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of AMT-151. 2) Evaluate the safety and tolerability of AMT-151. Secondary objectives: 1) Preliminary evaluation of the anti-tumor activity of AMT-151. 2) Evaluate the pharmacokinetic (PK) characteristics of AMT-151. 3) Evaluate the immunogenicity of AMT-151. Exploratory objectives: 1) Evaluate the pharmacodynamic (PD) characteristics of AMT-151. 2) Evaluate the effects of folate pathway blood markers on FRα expression and AMT-151 treatment response.

Start Date-

Sponsor / Collaborator

Multitude Therapeutics, Inc. (China)

100 Clinical Results associated with AMT-151

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100 Translational Medicine associated with AMT-151

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100 Patents (Medical) associated with AMT-151

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100 Deals associated with AMT-151

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of Lung	Phase 1	China	Multitude, Inc.	25 Jan 2023
Adenocarcinoma of Lung	Phase 1	China	Multitude Therapeutics, Inc. (China)	25 Jan 2023
Adenocarcinoma of Lung	Phase 1	Australia	Multitude, Inc.	25 Jan 2023
Adenocarcinoma of Lung	Phase 1	Australia	Multitude Therapeutics, Inc. (China)	25 Jan 2023
Advanced Malignant Solid Neoplasm	Phase 1	China	Multitude Therapeutics, Inc. (China)	25 Jan 2023
Advanced Malignant Solid Neoplasm	Phase 1	China	Multitude, Inc.	25 Jan 2023
Advanced Malignant Solid Neoplasm	Phase 1	Australia	Multitude Therapeutics, Inc. (China)	25 Jan 2023
Advanced Malignant Solid Neoplasm	Phase 1	Australia	Multitude, Inc.	25 Jan 2023
Endometrial Carcinoma	Phase 1	China	Multitude Therapeutics, Inc. (China)	25 Jan 2023
Endometrial Carcinoma	Phase 1	Australia	Multitude Therapeutics, Inc. (China)	25 Jan 2023

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Clinical Result

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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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