Clinical Trial · NCT01358903

A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Overview

This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.

Sponsor

Hoffmann-La Roche

Phase

Phase 1

Contacts

Clinical Trials (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT01358903

Drug / Compound

RO5429083

Isotope(s):

Target(s):

CD44v6

Ligand Class: Antibodies

Eligibility

Inclusion

Life expectancy of over 12 weeks
Metastatic and/or locally advanced malignant CD44-expressing solid tumors
Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy

Exclusion

Active or uncontrolled infections
Concurrent therapy with any other investigational drug
Known or suspected CNS metastases including leptomeningeal metastases
Patients with HIV infections
Active bleeding, bleeding diathesis or history of coagulation disorder
Uncontrolled diabetes mellitus