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, including Waldenström macroglobulinemia, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, lymphoplasmacytic lymphoma, and follicular lymphoma. It is currently in Phase 1 clinical development.
MDX2003 targets CD19, CD20, CD3, and CD28. It is classified as a T-cell engager-expander, a type of therapy designed to engage and expand T cells against cancer cells expressing these targets.
MDX2003 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The drug is currently in Phase 1 clinical trials for the treatment of lymphoma.
MDX2003 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 dose escalation and dose expansion study is currently recruiting participants with various types of lymphoma.
MDX2003 is being studied in a Phase 1 clinical trial registered as NCT07249905, titled 'Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma.' The trial is recruiting 180 participants in Australia and is open to adults aged 18 years and older.