A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/24/2018
Start Date:May 9, 2016
End Date:April 6, 2018

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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

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).


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
3
sites
Philadelphia, Pennsylvania 19104
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10 Avenue Hippocrate
Bruxelles, 1200
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Bruxelles,
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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