Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
NCT ID: NCT06239194
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
115 participants
INTERVENTIONAL
2024-06-12
2029-02-28
Brief Summary
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Detailed Description
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Primary Objectives
* All Phases: Evaluate the safety and tolerability of MDX2001 in patients with advanced solid tumor malignancies
* Phase 1 only: Identify a recommended Phase 2 dose (RP2D) for further development of MDX2001
* For Phase 1b and Phase 2: Assess the anti-tumor efficacy of MDX2001 in patients with selected advanced solid tumor malignancies
Secondary Objectives:
* Further characterize the anti-tumor activity of MDX2001 based on additional assessments of clinical benefit
* Characterize the pharmacokinetics of MDX2001
* Characterize the immunogenicity of MDX2001
* Characterize relationship of baseline target protein expression in tumor tissue and clinical benefit
The expected duration of study intervention for patients may vary, based on progression date. The median expected duration of study per patient is estimated to be 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a - MDX2001 Dose Escalation
Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.
MDX2001
MDX2001 intravenous infusion
Phase 1b - Dose Expansion - Dose A
Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.
MDX2001
MDX2001 intravenous infusion
Phase 1b - Dose Expansion - Dose B
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.
MDX2001
MDX2001 intravenous infusion
Phase 2a - Cohort Expansion
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.
MDX2001
MDX2001 intravenous infusion
Interventions
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MDX2001
MDX2001 intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 infectious 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
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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ModeX Therapeutics, An OPKO Health Company
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute
Denver, Colorado, United States
Sylvester Comprehensive Cancer Center - University of Miami Health System
Miami, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Jason Henry, MD
Role: primary
Melissa Johnson, MD
Role: primary
Ecaterina Dumbrava, MD
Role: primary
David Sommerhalder, MD
Role: primary
Other Identifiers
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MDX-2001-101
Identifier Type: -
Identifier Source: org_study_id
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