Dose Escalation and Dose Expansion Study of MDX2001 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 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 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.
Additional locations may be listed on ClinicalTrials.gov for NCT06239194.
Locations matching your search criteria
United States
Florida
Miami
Massachusetts
Boston
Texas
Houston
This study consists of Phase 1a dose escalation, Phase 1b dose expansion in a single
indication, and Phase 2a expansion in a single indication.
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).
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationModeX Therapeutics, An OPKO Health Company
- Primary IDMDX-2001-101
- Secondary IDsNCI-2024-06544
- ClinicalTrials.gov IDNCT06239194