Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07249905 | Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma | PHASE1 | RECRUITING | 180 | — | — | Apr 13, 2026 | Apr 1, 2030 | May 4, 2026 | 2 | Australia |
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...