Tests MDX2001 in adults with advanced solid tumors
Tests MDX2001 for safety and anti-tumor effects in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
Key facts
- Where
- Boston, Denver, Houston, Miami, Nashville, and San Antonio, United StatesSee the 6 sites
- Phase
- Phase 1/2
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
- Sarah Cannon Research InstituteDenver, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- Sylvester Comprehensive Cancer Center - University of Miami Health SystemMiami, United StatesTaking people
- Sarah Cannon Research InstituteNashville, United StatesTaking people
- NEXT OncologySan Antonio, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ModeX Therapeutics, An OPKO Health Company
- Trial code
- NCT06239194
- Record updated
- 15 October 2026
- Original description
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.Read full original descriptionShow less
A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Inclusion: 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: Unresolved toxicities from previous anticancer therapy; Prior solid organ or hematologic transplant; Participation in a concurrent clinical study in the treatment period; Any clinically significant cardiac disease; Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment; Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions; Known hypersensitivity to MDX2001 or any of its ingredients; Known untreated, active, or uncontrolled brain metastases; Receipt of a live-virus vaccination within 28 days of planned treatment start; 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.