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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07110584 | Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors | PHASE1 | RECRUITING | 235 | — | — | Oct 1, 2025 | Jun 30, 2031 | Mar 5, 2026 | 6 | Australia, Israel |
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...