Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors
1 other identifier
interventional
285
1 country
6
Brief Summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2024
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2024
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedStudy Start
First participant enrolled
June 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
May 6, 2026
May 1, 2026
4.1 years
January 18, 2024
May 3, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
All Phases: Adverse events (AEs)
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
Baseline until end of study, up to approximately 9 months
Phase 1b and Phase 2a: Objective response rate of MDX2001
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.
From date of enrollment until the end of treatment, up to approximately 6 months
Phase 1: Recommended Phase 2 dose (RP2D)
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
Baseline until end of study, up to approximately 9 months
Secondary Outcomes (9)
Phase 1a: Objective response rate of MDX2001
From date of enrollment until the end of treatment, up to approximately 6 months
All Phases: Duration of response (DOR)
From date of enrollment until the end of treatment, up to approximately 6 months
All Phases: Time to response (TTR)
From date of enrollment until the first documentation of response (CR or PR), approximately 4 months
All Phases: Disease control rate (DCR)
From date of enrollment until the end of treatment, up to approximately 6 months
All Phases: Progression free survival (PFS)
From date of enrollment until the end of treatment, up to approximately 6 months
- +4 more secondary outcomes
Study Arms (4)
Phase 1a - MDX2001 Dose Escalation
EXPERIMENTALPatients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.
Phase 1b - Indication Optimization
EXPERIMENTALPatients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.
Phase 1b - Dose Optimization
EXPERIMENTALPatients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.
Phase 2a - Cohort Expansion
EXPERIMENTALPatients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.
Interventions
MDX2001 intravenous infusion
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Sarah Cannon Research Institute
Denver, Colorado, 80218, United States
Sylvester Comprehensive Cancer Center - University of Miami Health System
Miami, Florida, 33136, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
Related Publications (1)
Dumbrava E, Minchom A, Henry J, Johnson M, Sommerhalder D, Merchan J, Heist R, Cabanas EG, Cotreau M, Goenaga AL, Burzyn D, Makris L, Culm K, Abbadessa G. MDX-2001-101 study protocol: a phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001 monotherapy in patients with advanced solid tumors. Future Oncol. 2026 Feb;22(3):305-312. doi: 10.1080/14796694.2025.2610468. Epub 2026 Jan 6.
PMID: 41495607DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2024
First Posted
February 2, 2024
Study Start
June 12, 2024
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share