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Phase 1Recruiting

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Sponsored by ModeX Therapeutics, An OPKO Health Company

About this study

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

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 tum…

Where this study is enrolling (6)

Show all 6 locations
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.