Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDX2004 · 1 trial · 1 indication
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
Maximum Tolerated Dose or Recommended Phase 2 dose is determined following the evaluation of MDX2004 safety including the incidences of dose limiting toxicities (DLTs), MDX2004 anti-tumor activity, and MDX2004 pharmacokinetics/pharmacodynamics.
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation - Part A | EXPERIMENTAL | Participants with advanced tumors will receive MDX2004 as intravenous (IV) infusion. |
| Indication Optimization - Part B | EXPERIMENTAL | Participants with select advanced tumors will receive MDX2004 as intravenous (IV) infusion. |
| Dose Optimization - Part C | EXPERIMENTAL | Participants with select advanced tumors will receive one of two recommended doses of MDX2004 as intravenous (IV) infusion. |
| Dose Expansion - Part D | EXPERIMENTAL | Participants with select advanced tumors will receive the recommended Phase 2 dose of MDX2004 as intravenous (IV) infusion. |
| Name | Type | Description |
|---|---|---|
| MDX2004 | DRUG | MDX2004 intravenous infusion |
Inclusion Criteria: * Participant must be ≥ 18 years of age. * Histologically or cytologically confirmed diagnosis of locally advanced or metastatic malignancy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * All participants should have at least 1 measurable site of dis...
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MDX2004 is an investigational small molecule being developed for the treatment of advanced tumors. It is currently in Phase 1 clinical development, with a study evaluating dose escalation and dose expansion in participants with advanced tumors.
MDX2004 targets CD3, a protein involved in T-cell signaling. By targeting CD3, the drug is designed to modulate immune responses in the context of oncology, though the specific mechanism of action is not fully detailed.
MDX2004 is being developed by Opko Health Inc., a biopharmaceutical company traded on the stock exchange under the ticker OPK. The company is conducting a Phase 1 clinical trial for this investigational therapy.
MDX2004 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in a dose escalation and dose expansion trial for advanced tumors.
MDX2004 is being studied in a Phase 1 clinical trial with the identifier NCT07110584. This trial is titled 'Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors' and is currently recruiting participants in Australia and Israel.
MDX2004 is the primary name for this investigational drug. No alternative names have been reported for this asset, which is being developed by Opko Health Inc. for advanced tumors.