SCCA Clinical Studies: Phase 1 Program
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 (Arm A and extension)/squamous cell carcinoma of the head and neck (Part B). 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.
- Adult patients, >/= 18 years of age
- Metastatic and/or locally advanced malignant CD44-expressing solid tumors (Arm A)
- Metastatic and/or locally advanced malignant CD44-expressing squamous cell carcinoma of the head and neck (Arm B)
- Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
- Life expectancy of over 12 weeks
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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