Phase 1 Study of Anti-HB-EGF Monoclonal Antibody KHK2866 as Monotherapy in Subjects With Advanced Solid Tumors and in Combination With Chemotherapy in Ovarian Cancer
During Phase 1a, groups of eligible patients with advanced solid tumors will receive KHK2866
as monotherapy in escalating doses. The Phase 1b portion will enroll patients with ovarian
cancer who will receive KHK2866 in combination with one of three chemotherapy regimens
(Arms): gemcitabine+carboplatin (platinum-sensitive, weekly paclitaxel (platinum-resistant),
or pegylated liposomal doxorubicin (platinum-resistant). Escalating doses of the
combination of KHK2866 and the chemotherapy regimen will given to two groups of subjects per
Arm. The goal of the study is to learn about the side effects of KHK2866 alone or given in
combination with chemotherapy. All subjects will receive study therapy for up to 6 cycles
(up to 12 cycles for subjects assigned to PLD [Arm 3 of Phase 1b]), or until disease
progression, the development of severe side effects, noncompliance or withdrawal of consent
by the subject, or other removal criteria whichever comes first.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The safety of KHK2866 will be determined by reported adverse events (AEs), changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations, and treatment discontinuation due to toxicity.
at least 60 days, and up to 6 months
Bruce A Silver, M.D.
Kyowa Hakko Kirin Pharma, Inc.
United States: Food and Drug Administration
|Arizona Cancer Center||Tucson, Arizona 85724|
|Oncology Consultants||Houston, Texas 77024|
|Cancer Therapy and Research Center||San Antonio, Texas 78229|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|USC Norris Comprehensive Cancer Center||Los Angeles, California 90089|
|Cedar Sinai-Samuel Oschin Comprehensive Cancer Institute||Los Angeles, California 90048|