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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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).

Key facts

Study ID

NCT02760797

Run by

Hoffmann-La Roche

People needed

38

Starts

2016-05-09

Expected to finish

2018-04-06

Last updated by the study team

2018-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Cliniques Universitaires St-Luc — Brussels, Belgium
• Centre Leon Berard; Departement Oncologie Medicale — Lyon, France
• Institut Claudius Regaud; Departement Oncologie Medicale — Toulouse, France
• Institut Gustave Roussy; Sitep — Villejuif, France

Full record on ClinicalTrials.gov

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