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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07110584
Registration number
NCT07110584
Ethics application status
Date submitted
24/07/2025
Date registered
7/08/2025
Date last updated
4/09/2025
Titles & IDs
Public title
Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors
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Scientific title
A Phase 1/2, Multi-Center, Open-Label Clinical Study Evaluating MDX2004 In Participants With Advanced Tumors
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Secondary ID [1]
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MDX-2004-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MDX2004
Experimental: Dose Escalation - Part A - Participants with advanced tumors will receive MDX2004 as intravenous (IV) infusion.
Experimental: Indication Optimization - Part B - Participants with select advanced tumors will receive MDX2004 as intravenous (IV) infusion.
Experimental: Dose Optimization - Part C - Participants with select advanced tumors will receive one of two recommended doses of MDX2004 as intravenous (IV) infusion.
Experimental: Dose Expansion - Part D - Participants with select advanced tumors will receive the recommended Phase 2 dose of MDX2004 as intravenous (IV) infusion.
Treatment: Drugs: MDX2004
MDX2004 intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All Study Parts: Adverse Events (AEs)
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Assessment method [1]
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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
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Timepoint [1]
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Baseline until 90 days after the participant has the last dose of MDX2004
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Primary outcome [2]
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Part A only - Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D)
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Assessment method [2]
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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.
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Timepoint [2]
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28 days
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Primary outcome [3]
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Part B, C, and D: Objective response rate of MDX2004
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Assessment method [3]
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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.
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Timepoint [3]
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From date of enrollment until the end of treatment, up to approximately 6 months
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Secondary outcome [1]
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All Study Parts: Measure of terminal half-life (t1/2) of MDX2004
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Assessment method [1]
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Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2004.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2004
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Assessment method [2]
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Characterize pharmacokinetic (PK) parameter AUC after intravenous infusion of MDX2004
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Timepoint [2]
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6 months
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Secondary outcome [3]
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All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2004
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Assessment method [3]
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Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2004
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Timepoint [3]
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6 months
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Secondary outcome [4]
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All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2004
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Assessment method [4]
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Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2004
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Timepoint [4]
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6 months
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Secondary outcome [5]
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All Study Parts: Measure of volume of distribution (Vd) of MDX2004
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Assessment method [5]
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Characterize pharmacokinetic (PK) parameter Vd after intravenous infusion of MDX2004.
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Timepoint [5]
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6 months
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Secondary outcome [6]
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All Study Parts: Measure of system clearance of MDX2004
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Assessment method [6]
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Characterize pharmacokinetic (PK) parameter of system clearance after intravenous infusion of MDX2004.
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Timepoint [6]
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6 months
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Secondary outcome [7]
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All Study Parts: Evaluation of MDX2004 immunogenicity
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Assessment method [7]
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The presence and persistence of anti-MDX2004 antibodies.
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Timepoint [7]
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6 months
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Secondary outcome [8]
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All Study Parts: Pharmacodynamic characterization of MDX2004
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Assessment method [8]
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Changes in T cell phenotypes with MDX2004 administration within the tumor microenvironment (TME) and in blood
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Timepoint [8]
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6 months
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Secondary outcome [9]
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All Study Parts: Duration of Response (DoR)
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Assessment method [9]
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Time from first Complete Response (CR) / Partial Response (PR) to the date of progressive disease (PD) or death, whichever occurs first.
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Timepoint [9]
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From date of enrollment until the end of treatment, up to approximately 6 months
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Secondary outcome [10]
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All Study Parts: Time to Response
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Assessment method [10]
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The time from first dose to first documentation of response (CR or PR).
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Timepoint [10]
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From date of enrollment until the end of treatment, up to approximately 6 months
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Secondary outcome [11]
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All Study Parts: Disease Control Rate (DCR)
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Assessment method [11]
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The proportion of evaluable participants with stable disease (SD) or a best overall response of CR or PR.
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Timepoint [11]
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From date of enrollment until the end of treatment, up to approximately 6 months
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Secondary outcome [12]
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All Study Parts: Progression Free Survival (PFS)
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Assessment method [12]
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The time from the first dose of MDX2004 until the date of disease progression (PD) or death (any cause), whichever occurs first.
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Timepoint [12]
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From date of enrollment until the end of treatment, up to approximately 6 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
30/09/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2031
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Actual
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Sample size
Target
235
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Calvary Mater Newcastle - Waratah
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Recruitment postcode(s) [1]
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2298 - Waratah
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ModeX Therapeutics, An OPKO Health Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.
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Trial website
https://clinicaltrials.gov/study/NCT07110584
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ModeX Therapeutics, An OPKO Health Company
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Address
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Country
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Phone
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+1 857-233-9936
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07110584
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