Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGRO5429083
Cohorts receiving multiple escalating doses iv
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arm A: Safety (Incidence of adverse events related to study drug) | Until disease progression or unacceptable toxicity (approximately 2 years) |
| Arm A: Maximum tolerated dose of RO5429083 | Until disease progression or unacceptable toxicity (approximately 2 years) |
| Arm A: Tumor Growth Control Rate | Until disease progression or unacceptable toxicity (approximately 2 years) |
| Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET) | Until disease progression or unacceptable toxicity (approximately 2 years) |
| Arm A: Pharmacokinetics (serum levels of RO5429083) | Until disease progression or unacceptable toxicity (approximately 2 years) |
Secondary
| Measure | Time frame |
|---|---|
| Arm A: Recommended dose of RO5429083 for the extension cohort | Until disease progression or unacceptable toxicity (approximately 2 years) |
| Arm A: Anti-tumor activity of RO5429083 | Until disease progression or unacceptable toxicity (approximately 2 years) |
| Arm B: Target saturation of 89Zr-labelled RO5429083 | Until disease progression or unacceptable toxicity (approximately 2 years) |
Countries
France, Netherlands, United States
Outcome results
None listed