Clinical Trials in the USA / NCT06239194
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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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