This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
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.
Trial sites (6)
Facility
City
Region
Status
Liverpool Hospital
Liverpool
New South Wales
Recruiting
Calvary Mater Newcastle
Waratah
New South Wales
Recruiting
Princess Alexandra Hospital
Woolloongabba
Queensland
Recruiting
Rambam Health Care Campus
Haifa
Israel
Recruiting
Hadassah University Hospital-Ein Kerem
Jerusalem
Israel
Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Israel
Recruiting
More ModeX Therapeutics, An OPKO Health Company trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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