MDX-2001-101試験プロトコル：進行固形がん患者を対象としたMDX2001単剤療法を評価する、ファーストインヒューマン、オープンラベルの多施設共同第I/IIa相臨床試験

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Updated: Jan 13, 2026

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts

Published on: July 25, 2020

Ecaterina Dumbrava¹, Anna Minchom², Jason Henry³

¹Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Future oncology (London, England)

|January 6, 2026

Abstract:

MDX2001 is a tetraspecific T-cell engager-expander antibody engineered to recognize four distinct antigens: cellular mesenchymal-epithelial transition factor (c-MET) and trophoblast antigen 2 (TROP2) to direct T cells to tumor cells, CD3 to activate T cells, and CD28 to enhance T-cell survival and proliferation. MDX2001 has demonstrated potent antitumor activity in nonclinical studies over a wide range of tumor types. Here, we present the protocol design for study MDX-2001-101, a multicenter, open-label, phase I/IIa clinical trial designed to evaluate the safety, tolerability, and antitumor effects of MDX2001 in patients with advanced solid tumors. The study comprises a phase Ia dose escalation guided by a Bayesian optimal interval design with a targeted maximum tolerated dose toxicity rate of 30%, a phase Ib dose expansion, and a phase IIa indication expansion.

キーワード:

CD28 CD3 MDX2001 TROP2 進行固形がん c-MET 多重特異性T細胞エンゲージャー試験プロトコル

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A Melanoma Patient-Derived Xenograft Model

A Melanoma Patient-Derived Xenograft Model

Published on: May 20, 2019

A Human Peripheral Blood Mononuclear Cell PBMC Engrafted Humanized Xenograft Model for Translational Immuno-oncology I-O Research

A Human Peripheral Blood Mononuclear Cell PBMC Engrafted Humanized Xenograft Model for Translational Immuno-oncology I-O Research

Published on: August 15, 2019

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