RecruitingPhase 1Phase 2NCT06239194

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

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors

Sponsor

ModeX Therapeutics, An OPKO Health Company

Enrollment

115 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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

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.