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Trial NCT06239194

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Phase
Phase 1/2
Sponsor
ModeX Therapeutics, An OPKO Health Company
Conditions
Biliary Tract Cancer; Breast Cancer; Cervical Cancer; Colon Cancer; Endometrial Cancer; Esophageal Cancer; Gastric Cancer; GastroEsophageal Cancer; Head and Neck Cancer; Hepatocellular Cancer; Non-small Cell Lung Cancer; Pancreatic Cancer; Prostate Cancer; Rectal Cancer; Renal Cancer; Thyroid Cancer; Urothelial Carcinoma (UC); Cholangiocarcinoma; Mesothelioma; Gallbladder Cancer; Ovarian Cancer
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Patients must be ≥ 18 years of age * Histologically or cytologically confirmed diagnosis of metastatic solid tumors * Eastern Cooperative Oncology Group (ECOG) performance status 0-1Performance status * All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion. * All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Adequate hematologic, hepatic and renal function * Capable of giving signed informed consent Exclusion Criteria: * Any clinically significant cardiac diseaseCardiac * Unresolved toxicities from previous anticancer therapy * Prior solid organ or hematologic transplant * Known untreated, active, or uncontrolled brain metastasesBrain metastases * Known positivity with human immunodeficiency virus (HIV)HIV, known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment. * Receipt of a live-virus vaccination within 28 days of planned treatment start * Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions. * Participation in a concurrent clinical study in the treatment period. * Known hypersensitivity to MDX2001 or any of its ingredients * Supplemental oxygen use for activities of daily living The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Restrictions found (4)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County