Last updated on March 2020

MGC018 With or Without MGA012 in Advanced Solid Tumors

Brief description of study

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGC018 administered alone and in combination with MGA012 in patients with advanced solid tumors.

Detailed Study Description

This Phase 1/2, bifurcated-design study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/administered dose (MTD/MAD) for MGC018 as monotherapy (Module

  1. or in combination with MGA012 (Module B) in patients with advanced solid tumors. Module B will commence after the MTD/MAD of MGC018 monotherapy is defined. Each module consists of a Dose Escalation (3+3+3 design) followed by a Cohort Expansion Phase. Patients with solid tumors of any histology will be enrolled in the Dose Escalation Phases; Cohort Expansion will include disease-specific cohorts. Patients who do not experience DLT/unacceptable toxicity or meet criteria for permanent discontinuation may undergo additional cycles. Patients will be followed for survival every 3 months for 2 years following last dose.

Clinical Study Identifier: NCT03729596

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