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

Cancer
Tumor
Neoplasms

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 1

Study Identifier NCT02760797, BP29427, 2015-004348-21

Condition Neoplasms

Official Title 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

Study Summary

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).

Eligibility Criteria

Gender

All

Age

≥ 18 Years

Healthy Volunteers

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

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com