Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors

Not Applicable

Recruiting

• Conditions: Advanced Tumors
• Interventions: Drug: MDX2004

• Registration Number: NCT07110584
• Lead Sponsor: ModeX Therapeutics, An OPKO Health Company

Brief Summary

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-30
• Status Verified: 2025-08
• Study First Posted: 2025-08-07
• Last Update Submitted: 2025-08-27
• Last Update Posted: 2025-09-04
• Study Start: 2025-09-30
• Primary Completion: 2031-06-30
• Study Completion: 2031-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 235

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 disease according to RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
• Adequate hematologic, hepatic and renal function.
• All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent.

Exclusion Criteria

• Any clinically significant cardiac disease.
• Unresolved toxicities from previous anticancer therapy.
• Known untreated, active, or uncontrolled brain metastases.
• Previous Grade 3 or 4 immune-related toxicity that led to the discontinuation of treatment, within 6 months prior to the first dose of MDX2004.
• Active medical condition requiring chronic systemic steroid use (>10 mg/day prednisone or equivalent) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2004.
• Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.
• Prior solid organ or hematologic transplant
• Require supplemental oxygen for activities of daily living
• Participant is not suitable for participation, whatever the reason, as judged by the Investigator including medical or clinical conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation - Part A	MDX2004	Participants with advanced tumors will receive MDX2004 as intravenous (IV) infusion.
Indication Optimization - Part B	MDX2004	Participants with select advanced tumors will receive MDX2004 as intravenous (IV) infusion.
Dose Optimization - Part C	MDX2004	Participants with select advanced tumors will receive one of two recommended doses of MDX2004 as intravenous (IV) infusion.
Dose Expansion - Part D	MDX2004	Participants with select advanced tumors will receive the recommended Phase 2 dose of MDX2004 as intravenous (IV) infusion.

Primary Outcome Measures

Name	Time	Method
Part B, C, and D: Objective response rate of MDX2004	From date of enrollment until the end of treatment, up to approximately 6 months	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.
All Study Parts: Adverse Events (AEs)	Baseline until 90 days after the participant has the last dose of MDX2004	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
Part A only - Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D)	28 days	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.

Secondary Outcome Measures

Name	Time	Method
All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2004	6 months	Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2004
All Study Parts: Measure of volume of distribution (Vd) of MDX2004	6 months	Characterize pharmacokinetic (PK) parameter Vd after intravenous infusion of MDX2004.
All Study Parts: Measure of system clearance of MDX2004	6 months	Characterize pharmacokinetic (PK) parameter of system clearance after intravenous infusion of MDX2004.
All Study Parts: Evaluation of MDX2004 immunogenicity	6 months	The presence and persistence of anti-MDX2004 antibodies.
All Study Parts: Disease Control Rate (DCR)	From date of enrollment until the end of treatment, up to approximately 6 months	The proportion of evaluable participants with stable disease (SD) or a best overall response of CR or PR.
All Study Parts: Measure of terminal half-life (t1/2) of MDX2004	6 months	Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2004.
All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2004	6 months	Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2004
All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2004	6 months	Characterize pharmacokinetic (PK) parameter AUC after intravenous infusion of MDX2004
All Study Parts: Pharmacodynamic characterization of MDX2004	6 months	Changes in T cell phenotypes with MDX2004 administration within the tumor microenvironment (TME) and in blood
All Study Parts: Duration of Response (DoR)	From date of enrollment until the end of treatment, up to approximately 6 months	Time from first Complete Response (CR) / Partial Response (PR) to the date of progressive disease (PD) or death, whichever occurs first.
All Study Parts: Time to Response	From date of enrollment until the end of treatment, up to approximately 6 months	The time from first dose to first documentation of response (CR or PR).
All Study Parts: Progression Free Survival (PFS)	From date of enrollment until the end of treatment, up to approximately 6 months	The time from the first dose of MDX2004 until the date of disease progression (PD) or death (any cause), whichever occurs first.

Trial Locations

Locations (1)

Calvary Mater Newcastle; 🇦🇺 Waratah, New South Wales, Australia