This study includes two parts: Phase I dose escalation and Phase II dose expansion. Phase I dose escalation aims to determine the MTD and/or RP2D of AMT-253 monotherapy and provide the initial safety, tolerability, efficacy, PK, and immunogenicity of AMT-253. Phase II dose expansion will further evaluate the safety, tolerability, and preliminary anti-tumor activity of AMT-253.

Start Date22 Feb 2024

Sponsor / Collaborator

Multitude Therapeutics, Inc. (China)

NCT06209580 / RecruitingPhase 1/2

Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors

This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.

Start Date31 Jan 2024

Sponsor / Collaborator

Multitude, Inc.

NCT05906862 / RecruitingPhase 1

First-in-Human, Phase 1 Study of AMT-253, in Patients With Advanced Solid Tumors

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-253, in Patients with Advanced Solid Tumors

Start Date06 Nov 2023

Sponsor / Collaborator

Multitude Therapeutics, Inc.

100 Clinical Results associated with AMT-253

100 Translational Medicine associated with AMT-253

100 Patents (Medical) associated with AMT-253

Literatures (Medical) associated with AMT-253

01 Jun 2024·Drugs in R&D

Antibody–Drug Conjugates in the Pipeline for Treatment of Melanoma: Target and Pharmacokinetic Considerations

Review

Author: Lami, Ina ; Wiemer, Andrew J

Melanoma is an aggressive, rapidly developing form of skin cancer that affects about 22 per 100,000 individuals. Treatment options for melanoma patients are limited and typically involve surgical excision of moles and chemotherapy. Survival has been improved in recent years through targeted small molecule inhibitors and antibody-based immunotherapies. However, the long-term side effects that arise from taking chemotherapies can negatively impact the lives of patients because they lack specificity and impact healthy cells along with the cancer cells. Antibody-drug conjugates are a promising new class of drugs for the treatment of melanoma. This review focuses on the development of antibody-drug conjugates for melanoma and discusses the existing clinical trials of antibody-drug conjugates and their use as a melanoma treatment. So far, the antibody-drug conjugates have struggled from efficacy problems, with modest effects at best, leading many to be discontinued for melanoma. At the same time, conjugates such as AMT-253, targeting melanoma cell adhesion molecule, and mecbotamab vedotin targeting AXL receptor tyrosine kinase, are among the most exciting for melanoma treatment in the future.

15 Nov 2023·Cancer Research

A Cell Surface-Binding Antibody Atlas Nominates a MUC18-Directed Antibody–Drug Conjugate for Targeting Melanoma

Article

Author: Hu, Wenhao ; Guo, Qian ; Tang, Yanfang ; Jiao, Tao ; Chen, Caiwei ; Huang, Yaling ; Guo, Jun ; Shi, Jing ; Liu, Shu-Hui ; Kong, Yan ; Meng, Xun ; Wang, Mingqiao ; Weng, Weining ; Meng, Tao ; Pan, Rong ; Zhang, Jianjian ; Zhang, Qing ; Ma, Linjie ; Wang, Lijun

AbstractRecent advances in targeted therapy and immunotherapy have substantially improved the treatment of melanoma. However, therapeutic strategies are still needed for unresponsive or treatment-relapsed patients with melanoma. To discover antibody–drug conjugate (ADC)–tractable cell surface targets for melanoma, we developed an atlas of melanoma cell surface–binding antibodies (pAb) using a proteome-scale antibody array platform. Target identification of pAbs led to development of melanoma cell killing ADCs against LGR6, TRPM1, ASAP1, and MUC18, among others. MUC18 was overexpressed in both tumor cells and tumor-infiltrating blood vessels across major melanoma subtypes, making it a potential dual-compartment and universal melanoma therapeutic target. AMT-253, an MUC18-directed ADC based on topoisomerase I inhibitor exatecan and a self-immolative T moiety, had a higher therapeutic index compared with its microtubule inhibitor–based counterpart and favorable pharmacokinetics and tolerability in monkeys. AMT-253 exhibited MUC18-specific cytotoxicity through DNA damage and apoptosis and a strong bystander killing effect, leading to potent antitumor activities against melanoma cell line and patient-derived xenograft models. Tumor vasculature targeting by a mouse MUC18-specific antibody–T1000-exatecan conjugate inhibited tumor growth in human melanoma xenografts. Combination therapy of AMT-253 with an antiangiogenic agent generated higher efficacy than single agent in a mucosal melanoma model. Beyond melanoma, AMT-253 was also efficacious in a wide range of MUC18-expressing solid tumors. Efficient target/antibody discovery in combination with the T moiety–exatecan linker–payload exemplified here may facilitate discovery of new ADC to improve cancer treatment.Significance:Discovery of melanoma-targeting antibodies using a proteome-scale array and use of a cutting-edge linker–payload system led to development of a MUC18-targeting antibody–exatecan conjugate with clinical potential for treating major melanoma subtypes.

100 Deals associated with AMT-253

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	CN	Multitude, Inc.	31 Jan 2024
Melanoma	Phase 2	CN	T-MAXIMUM Biopharmaceuticals (Suzhou) Co., Ltd.	-
Solid tumor	Preclinical	CN	Multitude Therapeutics, Inc.	22 Mar 2024
Solid tumor	Preclinical	US	Multitude Therapeutics, Inc.	22 Mar 2024

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