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Recruiting Phase 1/2

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

NCT06239194 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2024-06-12
Last updated
2026-10-15

Condition(s) studied

Biliary Tract CancerBreast CancerCervical CancerColon CancerEndometrial CancerEsophageal CancerGastric CancerGastroEsophageal CancerHead and Neck CancerHepatocellular CancerNon-small Cell Lung CancerPancreatic CancerProstate CancerRectal CancerRenal CancerThyroid CancerUrothelial Carcinoma (UC)CholangiocarcinomaMesotheliomaGallbladder CancerOvarian Cancer

Investigational drug(s) / intervention(s)

MDX2001

MDX2001: MDX2001 intravenous infusion or subcutaneous (SC) injection.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • All Phases: Adverse events (AEs) — Baseline until end of study, up to approximately 9 months
    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
  • Phase 1b and Phase 2a: Objective response rate of MDX2001 — From date of enrollment until the end of treatment, up to approximately 6 months
    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.
  • Phase 1: Recommended Phase 2 dose (RP2D) — Baseline until end of study, up to approximately 9 months
    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

Trial sites (6)

FacilityCityRegionStatus
Sarah Cannon Research Institute Denver Colorado Recruiting
Sylvester Comprehensive Cancer Center - University of Miami Health System Miami Florida Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
NEXT Oncology San Antonio Texas Recruiting

More ModeX Therapeutics, An OPKO Health Company trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06239194 on ClinicalTrials.gov ↗ ← All trials in the USA