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Emactuzumab

Phase 1

Neoplasms | Small molecule | Oncology |Roche Holding AG|Last Updated: May 22, 2018

Target and mechanism

Molecular targetCSF1R
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

Emactuzumab · 1 trial · 1 indication

Phase 1 1
NCT02760797A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid TumorsNeoplasms
COMPLETED38 Analytics
PHASE1COMPLETED
A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Up to 6 weeks from Day (D) 1 of Cycle (C) 1 (cycle = 3 weeks)

Secondary Endpoints

Percentage of Participants with Anti-Drug Antibodies (ADAs) to Emactuzumab
Predose (PrD) (0 hours [H]) on D1 each cycle (cycle = 3 weeks) until progressive disease (PD) (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)
Percentage of Participants with ADAs to RO7009789
PrD (0 H) on D1 each cycle (cycle = 3 weeks) until PD (up to 2 years); at 120 days after last dose (up to 2 years overall)
Serum Maximum Concentration (Cmax) of Emactuzumab
PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part I (Dose-Finding Stage)EXPERIMENTALEmactuzumab 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.
Part II (Dose Expansion Stage)EXPERIMENTALEmactuzumab 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.

Interventions

NameTypeDescription
EmactuzumabDRUGEmactuzumab 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.
RO7009789DRUGRO7009789 will be administered IV every 3 weeks (every cycle).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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 * ...

Countries:United StatesBelgiumFrance
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Frequently asked questions about Emactuzumab

What is Emactuzumab used for?

Emactuzumab is an investigational antibody being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 1 clinical development for this oncology indication.

Who makes Emactuzumab?

Emactuzumab is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY.

What phase is Emactuzumab in?

Emactuzumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is Emactuzumab in?

Emactuzumab has been studied in a completed Phase 1 clinical trial with the identifier NCT02760797. This trial evaluated Emactuzumab in combination with another investigational agent in participants with advanced solid tumors.

How does Emactuzumab work?

Emactuzumab is a monoclonal antibody, as indicated by its '-mab' suffix. Monoclonal antibodies are designed to bind to specific proteins in the body. The specific molecular target of Emactuzumab has not been disclosed in available information.