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

Roche

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Emactuzumab; Drug: RO7009789

Study type: Interventional

Funder types: Industry

Identifiers

NCT02760797

BP29427

2015-004348-21 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Part I (Dose-Finding Stage)

Experimental group

Description:

Emactuzumab and RO7009789 will be administered intravenously (IV) at a starting dose of 500 milligrams (mg) for emactuzumab and 2 mg for RO7009789. Treatment will continue as long as there is clinical benefit until unacceptable toxicity, symptomatic deterioration, or withdrawal of consent.

Treatment:

Drug: RO7009789

Drug: Emactuzumab

Part II (Dose Expansion Stage)

Experimental group

Description:

Emactuzumab and RO7009789 will be administered IV at the maximum tolerated dose defined in Part I of the study. Treatment will continue as long as there is clinical benefit until unacceptable toxicity, symptomatic deterioration, or withdrawal of consent.

Treatment:

Drug: RO7009789

Drug: Emactuzumab