Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors

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 MDX2004 in patients with advanced tumors.

Eligibility criteria

Qualifiers

Participant must be ≥ 18 years of age.

Histologically or cytologically confirmed diagnosis of locally advanced or metastatic malignancy.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

All participants should have at least 1 measurable site of disease according to 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.

Known untreated, active, or uncontrolled brain metastases.

Previous Grade 3 or 4 immune-related toxicity that led to the discontinuation of treatment, within 6 months prior to the first dose of MDX2004.

Trial design

Treatments tested in this trial

  • MDX2004

Treatment groups

235 Participants
are divided into 4 treatment groups