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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-09

Study Completion Date

2018-04-06

Brief Summary

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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).

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part I (Dose-Finding Stage)

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.

Group Type EXPERIMENTAL

Emactuzumab

Intervention Type DRUG

Emactuzumab will be administered IV every 3 weeks (every cycle) during Part I and every 3 or 6 weeks (every cycle or every other cycle) during Part II.

RO7009789

Intervention Type DRUG

RO7009789 will be administered IV every 3 weeks (every cycle).

Part II (Dose Expansion Stage)

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.

Group Type EXPERIMENTAL

Emactuzumab

Intervention Type DRUG

Emactuzumab will be administered IV every 3 weeks (every cycle) during Part I and every 3 or 6 weeks (every cycle or every other cycle) during Part II.

RO7009789

Intervention Type DRUG

RO7009789 will be administered IV every 3 weeks (every cycle).

Interventions

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Emactuzumab

Emactuzumab will be administered IV every 3 weeks (every cycle) during Part I and every 3 or 6 weeks (every cycle or every other cycle) during Part II.

Intervention Type DRUG

RO7009789

RO7009789 will be administered IV every 3 weeks (every cycle).

Intervention Type DRUG

Other Intervention Names

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RO5509554

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No