MDX-2001-101 study protocol: a phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001 monotherapy in patients with advanced solid tumors

Dumbrava E, Minchom A, Henry J, Johnson M, Sommerhalder D, Merchan J, Heist R, Cabanas EG et al.

Future oncology (London, England), 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.

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