NCT06239194 · ModeX Therapeutics, An OPKO Health Company
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
What this study is about
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
View original scientific description
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Interventions
DRUG
MDX2001
MDX2001 intravenous infusion
Primary outcome measures
All Phases: Adverse events (AEs)
Time frame: Baseline until end of study, up to approximately 9 months
Incidence and severity of AEs and serious AEs (SAEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 including changes in clinical laboratory parameters
Phase 1b and Phase 2a: Objective response rate of MDX2001
Time frame: 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.
Phase 1: Recommended Phase 2 dose (RP2D)
Time frame: Baseline until end of study, up to approximately 9 months
Recommended Phase 2 dose is determined following the evaluation of MDX2001 safety including the incidences of dose limiting toxicities (DLTs), MDX2001 anti-tumor activity, and MDX2001 pharmacokinetics
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 0-1
- 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
Exclusion criteria
- 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 c
Where
- Denver, Colorado
- Miami, Florida
- Boston, Massachusetts
- Nashville, Tennessee
- Houston, Texas
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations