Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- ModeX Therapeutics, An OPKO Health Company
- Study ID
- NCT06239194
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
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
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- MDX2001 — DRUGMDX2001 intravenous infusion
Study Details
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Key Dates
- Start date
- Jun 12, 2024
- Status verified
- May 2026
- Primary completion
- Aug 31, 2028
- Completion
- Feb 28, 2029
Study Design
- Enrollment
- 285 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Phase 1a - MDX2001 Dose EscalationPatients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.
- Experimental: Phase 1b - Indication OptimizationPatients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.
- Experimental: Phase 1b - Dose OptimizationPatients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.
- Experimental: Phase 2a - Cohort ExpansionPatients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.
Primary Outcome Measure
All Phases: Adverse events (AEs) [ Time Frame: Baseline until end of study, up to approximately 9 months ]
Central Contacts
- Email recommended(857) 233-9936
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | Gerald Falchook, MD (PRINCIPAL_INVESTIGATOR) |
| Sylvester Comprehensive Cancer Center - University of Miami Health System | Miami | Florida | 33136 | Jaime Merchan, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Rebecca Heist, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | Melissa Johnson, MD (PRINCIPAL_INVESTIGATOR) |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Ecaterina Dumbrava, MD (PRINCIPAL_INVESTIGATOR) |
| NEXT Oncology | San Antonio | Texas | 78229 | David Sommerhalder, MD (PRINCIPAL_INVESTIGATOR) |
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