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MDX-2001-101 study protocol: a phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001

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
PubMed

Insights

MDX2001, a novel tetraspecific antibody, targets cellular mesenchymal-epithelial transition factor (c-MET) and trophoblast antigen 2 (TROP2) to direct T cells to tumors. This antibody shows potent antitumor activity and will be evaluated in a phase I/IIa clinical trial.

Area of Science:

  • Oncology
  • Immunotherapy
  • Antibody Engineering

Background:

  • MDX2001 is a tetraspecific T-cell engager-expander antibody.
  • It targets cellular mesenchymal-epithelial transition factor (c-MET), trophoblast antigen 2 (TROP2), CD3, and CD28.
  • MDX2001 has shown potent antitumor activity in preclinical studies across various tumor types.

Purpose of the Study:

  • To evaluate the safety and tolerability of MDX2001 in patients with advanced solid tumors.
  • To assess the antitumor effects of MDX2001.
  • To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).

Main Methods:

  • Study MDX-2001-101 is a multicenter, open-label, phase I/IIa clinical trial.
  • Phase Ia involves dose escalation using a Bayesian optimal interval design.
  • Phase Ib and IIa involve dose expansion and indication expansion, respectively.

Main Results:

  • Preclinical studies demonstrated potent antitumor activity of MDX2001.
  • The clinical trial is designed to evaluate safety, tolerability, and antitumor effects.
  • Specific results from the clinical trial are pending.

Conclusions:

  • MDX2001 is a promising T-cell engager-expander antibody with demonstrated preclinical efficacy.
  • The phase I/IIa trial will provide crucial safety and efficacy data for advanced solid tumors.
  • MDX2001 has the potential to offer a new therapeutic option for cancer patients.
Keywords:
CD28CD3MDX2001TROP2advanced solid tumorc-metmultispecific T-cell engagerstudy protocol

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