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

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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Publication Details

Journal
Future Oncology
Published
2026-01-06
DOI
https://doi.org/10.1080/14796694.2025.2610468
Primary Topic
Monoclonal and Polyclonal Antibodies Research
Type
article
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article

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

Kerry Culm, Anne-Laure Goenaga, Jaime R. Merchan, Melissa L. Johnson et al.
Future Oncology
Monoclonal and Polyclonal Antibodies Research
article

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

Kerry Culm, Anne-Laure Goenaga, Jaime R. Merchan, Melissa L. Johnson, Lukas Makris, E Dumbravă, Elena Garralda, David Sommerhalder, Rebecca S. Heist, Dalia Burzyn, Jason T. Henry, Anna Rachel Minchom, Monette Cotreau, Giovanni Abbadessa
article en

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.

Future OncologyVol. 22(3)
Royal Marsden NHS Foundation Trust (GB), The University of Texas MD Anderson Cancer Center (US), Sarah Cannon Research Institute (GB), Massachusetts General Hospital (US), OPKO Health (United States) (US), DM-STAT (United States) (US), Sylvester Comprehensive Cancer Center (US), HealthPartners (US)
Good health and well-being
Openalex Percentile: Top 97%
Monoclonal and Polyclonal Antibodies Research
DOIOpen Access PDFOpenAlex
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