ModeX Therapeutics, An OPKO Health Company
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
This study consists of Phase 1a dose escalation, Phase 1b dose expansion in a single indication, and Phase 2a expansion in a single indication. Primary Objectives * All Phases: Evaluate the safety and tolerability of MDX2001 in patients with advanced solid tumor malignancies * Phase 1 only: Identify a recommended Phase 2 dose (RP2D) for further development of MDX2001 * For Phase 1b and Phase 2: Assess the anti-tumor efficacy of MDX2001 in patients with selected advanced solid tumor malignancies Secondary Objectives: * Further characterize the anti-tumor activity of MDX2001 based on additio…
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 a…
MDX2001 intravenous infusion