This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
Interventions
Drug: MDX2001 — MDX2001 intravenous infusion or subcutaneous (SC) injection.
Primary outcomes
All Phases: Adverse events (AEs) (Baseline until end of study, up to approximately 9 months)
Phase 1b and Phase 2a: Objective response rate of MDX2001 (From date of enrollment until the end of treatment, up to approximately 6 months)
Phase 1: Recommended Phase 2 dose (RP2D) (Baseline until end of study, up to approximately 9 months)
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
Sarah Cannon Research Institute, Denver, Colorado 80218 United States
Sylvester Comprehensive Cancer Center - University of Miami Health System, Miami, Florida 33136 United States
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Sarah Cannon Research Institute, Nashville, Tennessee 37203 United States
MD Anderson Cancer Center, Houston, Texas 77030 United States
NEXT Oncology, San Antonio, Texas 78229 United States
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.