Health TrialsbyHealthPanel

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

ConditionAdvanced Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorModeX Therapeutics, An OPKO Health Company

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MDX2004

    Drug

    MDX2004 intravenous infusion

Treatment groups

235 Participants
are divided into 4 treatment groups
Group A: Dose Escalation - Part AExperimental treatment 1 intervention
Group B: Indication Optimization - Part BExperimental treatment 1 intervention
Group C: Dose Optimization - Part CExperimental treatment 1 intervention
Group D: Dose Expansion - Part DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline until 90 days after the participant has the last dose of MDX2004
2

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.

Time frame
28 days
3

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.

Time frame
From date of enrollment until the end of treatment, up to approximately 6 months

Secondary outcomes

1

All Study Parts: Measure of terminal half-life (t1/2) of MDX2004

Characterize pharmacokinetic (PK) parameter t1/2 after intravenous infusion of MDX2004.

Time frame
6 months
2

All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2004

Characterize pharmacokinetic (PK) parameter AUC after intravenous infusion of MDX2004

Time frame
6 months
3

All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2004

Characterize pharmacokinetic (PK) parameter Tmax after intravenous infusion of MDX2004

Time frame
6 months
4

All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2004

Characterize pharmacokinetic (PK) parameter Cmax after intravenous infusion of MDX2004

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ModeX Therapeutics, An OPKO Health Company

Lead sponsor

Source ClinicalTrials.gov
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