Evidence map›Paper›PMID 41495607›Full record

ArticleFuture oncology (London, England)2026

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.

Ecaterina Dumbrava, Anna Minchom, Jason Henry, Melissa Johnson, David Sommerhalder, Jaime Merchan, Rebecca Heist, Elena Garralda Cabanas, Monette Cotreau, Anne-Laure Goenaga and 4 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Future oncology (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ecaterina DumbravaDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Anna MinchomDrug Development Phase 1 Unit, The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust, Sutton, UK.
Jason HenryDenver Drug Deveopment Unit, Sarah Cannon Research Institute at Healthone, Denver, CO, USA.
Melissa JohnsonLung Cancer Research, Sarah Cannon Research Institute, Nashville, TN, USA.
David SommerhalderSan Antonio Team, NEXT Oncology, San Antonio, TX, USA.
Jaime MerchanDepartment of Medicine, Sylvester Comprehensive Cancer Center, Miami, FL, USA.
Rebecca HeistHarvard Medical School, Massachusetts General Hospital, Boston, MA, USA.
Elena Garralda CabanasBarcelona Team, NEXT Oncology, Barcelona, Spain.
Monette CotreauMMC Biopartners, Rye, NH, USA.
Anne-Laure GoenagaModeX Therapeutics, An OPKO Health Company, Weston, MA, USA.
Dalia BurzynModeX Therapeutics, An OPKO Health Company, Weston, MA, USA.
Lukas MakrisStathmi, Inc., New Hope, PA, USA.
Kerry CulmModeX Therapeutics, An OPKO Health Company, Weston, MA, USA.
Giovanni AbbadessaModeX Therapeutics, An OPKO Health Company, Weston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Antineoplastic Agents, ImmunologicalNeoplasmsAdultAgedClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicFemaleHumansMaleMaximum Tolerated DoseMiddle AgedMulticenter Studies as TopicTreatment OutcomeAntineoplastic Agents, Immunologicaladvanced solid tumorCD28CD3c-metMDX2001multispecific T-cell engagerstudy protocolTROP2

Identifiers

PMID41495607
PMCPMC12867436

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.