MDX2004 / OPKO Health - LARVOL DELTA

A phase 1/2a, multicenter, first-in-human, open-label clinical trial evaluating MDX2004 monotherapy in patients with advanced tumors. (ASCO 2026) - P1/2 | "Radiologic tumor assessments are performed every 8 weeks, and treatment continues until disease progression per RECIST v1.1 (investigator assessed), unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion. The study is planned to be conducted in Australia, Israel, Moldova; patient recruitment is ongoing."

Clinical • First-in-human • Metastases • Monotherapy • P1/2 data • Oncology • Solid Tumor

A phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating monotherapy with MDX2004, a trispecific antibody-fusion protein in patients with advanced tumors (ESMO-TAT 2026) - P1/2 | "The study will be conducted in Australia, Israel, Moldova, United States, and Europe. Recruitment is ongoing.Clinical trial identification: NCT07110584."

Clinical • First-in-human • Metastases • Monotherapy • P1/2 data • Trispecific • Oncology • Solid Tumor

MDX2004, a novel immune rejuvenator targeting CD3, CD28, and 4-1BB, augments tumor immunity in preclinical animal models (SITC 2025) - "NHP study conducted at ALtasciences (Everett, WA, USA). The Testing Facility is accredited by AAALAC International, has an Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW), is registered with the United States Department of Agriculture (USDA), and has an Institutional Animal Care and Use Committee (IACUC) responsible for the Testing Facility's compliance with applicable laws and regulations concerning the humane care and use of laboratory animals."

Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • CD8 • TNFRSF9

First-in-human dosing model for MDX2004, a novel trispecific CD3xCD28/4-1BB antibody-fusion protein for advanced malignancies (SITC 2025) - "Metrics for proposed doses were based on model-predicted estimates for T cell activation, cytokine release and tumor growth inhibition.Results Based upon effective concentrations for T cell activation, the model predicted a MABEL of 18.5 mg/kg. The model predicted an efficacious dose in the high mg/kg range based upon effective concentrations for both T cell activation and tumor growth inhibition.Conclusions The final QSP model was successful in informing dose selections for the FIH study with MDX2004 in participants with advanced malignancies."

First-in-human • Metastases • P1 data • Trispecific • Oncology

Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors (clinicaltrials.gov) - P1/2 | N=235 | Recruiting | Sponsor: ModeX Therapeutics, An OPKO Health Company | Not yet recruiting ➔ Recruiting

Enrollment open

Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors (clinicaltrials.gov) - P1/2 | N=235 | Not yet recruiting | Sponsor: ModeX Therapeutics, An OPKO Health Company

New P1/2 trial