Clinical Trial · NCT01482377

A Study of RO5479599 Alone or in Combination With Cetuximab or Erlotinib in Participants With Metastatic and/or Locally Advanced Malignant Human Epidermal Growth Factor Receptor (HER3) Expressing Solid Tumors of Epithelial Cell Origin

Overview

This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety, pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or erlotinib, in participants with metastatic and/or locally advanced malignant HER3-positive solid tumors. Cohorts of participants will receive escalating doses of intravenous RO5479599 as monotherapy (Part A) or in combination with cetuximab (in Part B) or with erlotinib (in Part C) followed by an extension phase for each part. In an imaging substudy, participants will receive one or two doses of zirconium-89-labeled RO5479599 (89ZrRO5479599) in addition to unlabeled RO5479599 to evaluate the in vivo biodistribution and organ pharmacokinetics of RO5479599.

Sponsor

Hoffmann-La Roche

Phase

Phase 1

Contacts

Clinical Trials (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT01482377

Drug / Compound

RO5479599

Isotope(s):

Target(s):

HER3

Ligand Class: Antibodies

Eligibility

Inclusion

All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure must have resolved to Grade less than or equal to (\</= 1), except for alopecia and Grade 2 peripheral neuropathy
Adequate hematological, renal and liver function
European Cooperative Oncology Group (ECOG) performance status 0-2
Availability of tissue and willingness to perform fresh pretreatment biopsies
Histologically confirmed metastatic and/or locally advanced malignant HER3-expressing solid tumors of epithelial origin
All Parts (A, B and C)
Participants for whom no standard therapy exists

Exclusion

Known or clinically suspected central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases. History or clinical evidence of CNS metastases unless they have been previously treated, are asymptomatic and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days
Therapy with antibody or immunotherapy concurrently or within 14 days prior to first dose of study drug
Evidence of significant uncontrolled concomitant diseases or disorders
Concurrent high dose of systemic corticosteroids (greater than (\>) 20 milligrams per day \[mg/day\] dexamethasone or equivalent for \> 7 consecutive days)
Known Human immuno deficiency virus (HIV) infection
Regular immunosuppressive therapy
Active or uncontrolled infections