Two-Part, Open-Label, Multi-Center Phase 1 Study of Monoclonal Antibody CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors
The study will be conducted in two parts. In Part 1, a standard 3+3 designed dose
escalation phase, subjects will receive CEP-37250/KHK2804, administered iv, once every week.
A treatment cycle will consists of total of four doses per cycle. Part 2 of the study will
enroll subjects with either colon cancer or pancreatic cancer to receive CEP-37250/KHK2804
at a dose to be determined following completion of Part 1.
All subjects will receive study therapy until disease progression, the development of
unacceptable toxicity, noncompliance or withdrawal of consent by the subject, or
Investigator decision, up to a maximum of six cycles (approximately six months). After six
cycles of CEP-37250/KHK2804 therapy, the subject may continue to receive CEP-37250/KHK2804
after discussion with the Sponsor and determination that the subject is experiencing a best
response of at least stable disease (SD) and is not experiencing any unacceptable toxicities
or dose limiting toxicities (DLTs).
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse Event collection and assessment will be done for all 74 potentially treated subjects.
The safety of CEP-37250/KHK2804 will be determined by reported adverse events (AEs), changes in the physical examinations, vital laboratory evaluations, and treatment discontinuations due to toxicity.
at least 30 days or up to 12 weeks
Bruce Silvers, MD
Kyowa Hakko Kirin Pharma, Inc.
United States: Food and Drug Administration
|Cedars Sinai Medical Center||Los Angeles, California 90048-1804|
|The Ohio State University||Columbus, Ohio 43210|
|Emory University||Atlanta, Georgia 30322|
|Mary Crowley Cancer Center||Dallas, Texas 75246|
|UNC - Chapel Hill||Chapel Hill, North Carolina 27599|