A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors
- United States
NCT02760797 2015-004348-21 BP29427
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of emactuzumab and RO7009789 administered in combination in participants with locally advanced or metastatic solid tumors that are not amenable to standard treatment. This study will be conducted in two parts: a dose-finding stage (Part I) and an expansion stage (Part II).
An Open-Label, Multicenter, Dose-Escalation Phase Ib Study With Expansion Phase to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Emactuzumab and RO7009789 Administered in Combination in Patients With Advanced Solid Tumors
- Eastern Cooperative Oncology Group performance status 0 or 1
- Histologically confirmed diagnosis of locally advanced, recurrent, and/or metastatic triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, pancreatic cancer, melanoma, or mesothelioma
- Radiologically measurable and clinically evaluable disease as per RECIST v1.1
- Life expectancy of greater than or equal to (>/=) 16 weeks
- Ability to comply with the collection of tumor biopsies; tumors accessible for biopsy
- Adequate bone marrow, liver, cardiac, and renal function
- Allergy or hypersensitivity to components of either study drug formulation
- Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments. Participants with radiographically stable, asymptomatic, previously irradiated lesions are eligible provided participant is >/=4 weeks beyond completion of cranial irradiation and >/=3 weeks off of corticosteroid therapy
- Participants with leptomeningeal disease; metastases to the brain stem, midbrain, pons, medulla, or within 10 millimeters (mm) of the optic apparatus (optic nerves and chiasm)
- History of human immunodeficiency virus (HIV)
- Participants with active hepatitis B, active hepatitis C, or active tuberculosis
- Pregnant or lactating women
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