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RO7009789

Phase 1

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

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

RO7009789 · 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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