Testing MDX2001 for advanced solid tumors
A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors
This study is testing a new drug called MDX2001 to see if it can safely help people with advanced solid tumors like breast or colon cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 285 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ModeX Therapeutics, An OPKO Health Company Industry-sponsored |
| Locations | 6 sites (Denver, Colorado and 5 other locations) |
| Trial ID | NCT06239194 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors, including biliary tract, breast, cervical, colon, and endometrial cancers. It consists of a Phase 1a dose escalation to determine the recommended Phase 2 dose, followed by a Phase 1b and Phase 2a expansion focusing on a single indication. The study aims to assess the drug's efficacy and further characterize its pharmacokinetics and immunogenicity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic solid tumors and an ECOG performance status of 0-1.
Not a fit: Patients with significant cardiac disease, unresolved toxicities from prior treatments, or active brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: Other studies have shown promise with similar approaches, but the specific application of MDX2001 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Denver, Colorado and 5 other locations
- Sarah Cannon Research Institute — Denver, Colorado, United States (Recruiting)
- Sylvester Comprehensive Cancer Center - University of Miami Health System — Miami, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Email recommended
- Email: info@modextx.com
- Phone: (857) 233-9936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.