Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: 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
In brief
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Key facts
- Study ID
- NCT06239194
- Run by
- ModeX Therapeutics, An OPKO Health Company
- People needed
- 285
- Starts
- 2024-06-12
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be ≥ 18 years of age
- Histologically or cytologically confirmed diagnosis of metastatic solid tumors
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 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
You may not qualify if…
- Any clinically significant cardiac disease
- Unresolved toxicities from previous anticancer therapy
- Prior solid organ or hematologic transplant
- Known untreated, active, or uncontrolled brain metastases
- Known positivity with human immunodeficiency virus (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.
Where it is running
- Sarah Cannon Research Institute — Denver, Colorado, United States (enrolling)
- Sylvester Comprehensive Cancer Center - University of Miami Health System — Miami, Florida, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- NEXT Oncology — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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