Health Trials

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

ConditionsBiliary Tract CancerBreast CancerCervical CancerColon CancerEndometrial CancerEsophageal CancerGastric CancerGastroEsophageal CancerHead and Neck CancerHepatocellular CancerNon-small Cell Lung CancerPancreatic CancerProstate CancerRectal CancerRenal CancerThyroid Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorModeX Therapeutics, An OPKO Health Company

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

Any clinically significant cardiac disease

Unresolved toxicities from previous anticancer therapy

Prior solid organ or hematologic transplant

Known untreated, active, or uncontrolled brain metastases

Trial design

Treatments tested in this trial

  • MDX2001

Treatment groups

285 Participants
are divided into 4 treatment groups

Locations

6
Sarah Cannon Research Institute80218, DenverColorado, United States
Sylvester Comprehensive Cancer Center - University of Miami Health System33136, MiamiFlorida, United States
Massachusetts General Hospital02114, BostonMassachusetts, United States
Sarah Cannon Research Institute37203, NashvilleTennessee, United States

Sponsors and collaborators

ModeX Therapeutics, An OPKO Health Company

Lead sponsor

Source ClinicalTrials.gov