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This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation - Part A | Experimental | Participants with advanced tumors will receive MDX2004 as intravenous (IV) infusion. |
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| Indication Optimization - Part B | Experimental | Participants with select advanced tumors will receive MDX2004 as intravenous (IV) infusion. |
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| Dose Optimization - Part C | Experimental | Participants with select advanced tumors will receive one of two recommended doses of MDX2004 as intravenous (IV) infusion. |
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| Dose Expansion - Part D | Experimental | Participants with select advanced tumors will receive the recommended Phase 2 dose of MDX2004 as intravenous (IV) infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDX2004 | Drug | MDX2004 intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| All Study Parts: Adverse Events (AEs) | 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 | Baseline until 90 days after the participant has the last dose of MDX2004 |
| Part A only - Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D) | 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. | 28 days |
| Part B, C, and D: Objective response rate of MDX2004 | 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. | From date of enrollment until the end of treatment, up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| All Study Parts: Measure of terminal half-life (t1/2) of MDX2004 | Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2004. | 6 months |
| All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2004 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ModeX Therapeutics, An OPKO Health Company | Contact | +1 857-233-9936 | info@modextx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Recruiting | Liverpool | New South Wales | 2170 | Australia |
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Characterize pharmacokinetic (PK) parameter AUC after intravenous infusion of MDX2004 |
| 6 months |
| All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2004 | Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2004 | 6 months |
| All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2004 | Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2004 | 6 months |
| All Study Parts: Measure of volume of distribution (Vd) of MDX2004 | Characterize pharmacokinetic (PK) parameter Vd after intravenous infusion of MDX2004. | 6 months |
| All Study Parts: Measure of system clearance of MDX2004 | Characterize pharmacokinetic (PK) parameter of system clearance after intravenous infusion of MDX2004. | 6 months |
| All Study Parts: Evaluation of MDX2004 immunogenicity | The presence and persistence of anti-MDX2004 antibodies. | 6 months |
| All Study Parts: Pharmacodynamic characterization of MDX2004 | Changes in T cell phenotypes with MDX2004 administration within the tumor microenvironment (TME) and in blood | 6 months |
| All Study Parts: Duration of Response (DoR) | Time from first Complete Response (CR) / Partial Response (PR) to the date of progressive disease (PD) or death, whichever occurs first. | From date of enrollment until the end of treatment, up to approximately 6 months |
| All Study Parts: Time to Response | The time from first dose to first documentation of response (CR or PR). | From date of enrollment until the end of treatment, up to approximately 6 months |
| All Study Parts: Disease Control Rate (DCR) | The proportion of evaluable participants with stable disease (SD) or a best overall response of CR or PR. | From date of enrollment until the end of treatment, up to approximately 6 months |
| All Study Parts: Progression Free Survival (PFS) | The time from the first dose of MDX2004 until the date of disease progression (PD) or death (any cause), whichever occurs first. | From date of enrollment until the end of treatment, up to approximately 6 months |
| Calvary Mater Newcastle | Recruiting | Waratah | New South Wales | 2298 | Australia |
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| Princess Alexandra Hospital | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
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| Rambam Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
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| Hadassah University Hospital-Ein Kerem | Recruiting | Jerusalem | 9574409 | Israel |
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| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
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