drugset / Trial / NCT03013491

PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

NCT03013491

Phase 1/2 Terminated 196 enrolled CytomX Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial CX-072 is a Probody® therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity. PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc.

Timeline

Start
2017-01-19
Primary completion
2020-10-27
Completion
2020-10-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Ipilimumab Monoclonal antibody 6 mg/kg Intravenous
Subject Ipilimumab Monoclonal antibody 10 mg/kg Intravenous
Subject Pacmilimab Monoclonal antibody 0.3 mg/kg Intravenous
Subject Pacmilimab Monoclonal antibody 1 mg/kg Intravenous
Subject Pacmilimab Monoclonal antibody 3 mg/kg Intravenous
Subject Pacmilimab Monoclonal antibody 10 mg/kg Intravenous
Subject Vemurafenib Small molecule

Indications