Recruiting

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.

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ClinicalTrials.gov IDNCT06239194
PhasePHASE1, PHASE2
Enrollment330
SponsorModeX Therapeutics, An OPKO Health Company
Age18 Years and older
SexALL
I'm interested View official listing

Conditions studied

Biliary Tract Cancer, Breast Cancer, Cervical Cancer, Colon Cancer, Endometrial Cancer, Esophageal Cancer, Gastric Cancer, GastroEsophageal Cancer, Head and Neck Cancer, Hepatocellular Cancer, Non-small Cell Lung Cancer, Pancreatic Cancer, Prostate Cancer, Rectal Cancer, Renal Cancer, Thyroid Cancer, Urothelial Carcinoma (UC), Cholangiocarcinoma, Mesothelioma, Gallbladder Cancer, Ovarian Cancer

About this study

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

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-09.