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Recruiting Phase 1/2 NCT07110584

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

Phase 1/2 – combined early trial
Conditions: Advanced Tumors

Sponsor: ModeX Therapeutics, An OPKO Health Company

trial.available_in: БГ
Overview
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.
Who can participate
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.
Locations 2
Australia (1)
Liverpool Hospital
Liverpool , New South Wales
Israel (1)
Rambam Health Care Campus
Haifa
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.10.2025
Completion date
30.06.2031
Registry ID
NCT07110584
Source
anzctr
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