Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDX2003 · 1 trial · 8 indications
Maximum Tolerated Dose is determined following the evaluation of MDX2003 safety, including the incidences of dose-limiting toxicities (DLTs), MDX2003 anti-tumor activity, and MDX2003 pharmacokinetics/pharmacodynamics.
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria, including changes in clinical laboratory parameters.
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Lugano Classification.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation- Part A | EXPERIMENTAL | Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion. |
| Indication Optimization- Part B | EXPERIMENTAL | Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion. |
| Name | Type | Description |
|---|---|---|
| MDX2003 | DRUG | MDX2003 intravenous infusion |
Inclusion Criteria: * Participant must be ≥ 18 years of age. * Participant has a confirmed diagnosis of large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma \[HGBCL\], primary mediastinal B-cell lymphoma \[PMBCL\], etc), FL, MCL, marginal zone lymphoma, transformation of indolent B-ce...
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MDX2003 is an investigational small molecule being developed for the treatment of lymphoma. It is currently being studied in a Phase 1 clinical trial in patients with different types of lymphoma, including Waldenström macroglobulinemia, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma.
MDX2003 targets CD19, CD20, CD3, and CD28. It is a tetraspecific T-cell engager-expander, a type of therapy designed to engage and expand T-cells against cancer cells that express these targets.
MDX2003 is being developed by Opko Health Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol OPK.
MDX2003 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is currently being evaluated in an early-stage clinical trial to assess its safety and dosing in patients with lymphoma.
MDX2003 is being studied in a Phase 1 clinical trial with the identifier NCT07249905. This is a dose escalation and dose expansion study in patients with different types of lymphoma. The trial is currently recruiting participants in Australia and aims to enroll approximately 180 patients.
No alternative names for MDX2003 have been reported. The drug is identified solely by its code name MDX2003 in clinical development.