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

Hoffmann-La Roche65 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

RO5429083DRUG

Cohorts receiving multiple escalating doses iv

RO5429083DRUG

Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * 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 * Life expectancy of over 12 weeks Exclusion Criteria: * Concurrent therapy with any other investigational drug * Known or suspected CNS metastases including leptomeningeal metastases * Active bleeding, bleeding diathesis or history of coagulation disorder * Uncontrolled diabetes mellitus * Active or uncontrolled infections * Patients with HIV infections

Locations (6)

Unnamed facility

Houston, Texas, United States

Unnamed facility

Seattle, Washington, United States

Unnamed facility

Paris, France

Unnamed facility

Toulouse, France

Unnamed facility