This is a two-part, Phase 1, open-label, multicenter, dose escalation study of KHK2866 as monotherapy in patients with advanced solid tumors, and in combination with chemotherapy in subjects platinum-sensitive and platinum-resistant 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Potentially therapeutic monoclonal antibody for the treatment of advanced cancer and ovarian cancer.
Combination chemotherapy with KHK2866 to treat advanced platinum-sensitive ovarian cancer. Gemcitabine dose 1000 mg/m2, Carboplatin dose AUC=4
Combination chemotherapy with KHK2866 to treat advanced platinum-resistant ovarian cancer. Paclitaxel will be administered weekly at a dose of 80 mg/m2.
Arizona Cancer Center
Tucson, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cedar Sinai-Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
Time frame: at least 60 days, and up to 6 months
To determine the Cmax, Tmax, AUC and half life of KHK2866 when administered i.v. as monotherapy
Participants will have serial blood samples taken to determine the PK profile of the study drug.
Time frame: at least 28 days and up to 6 months
To evaluate the changes in serum HB-EGf in participants administered KHK2866
Participants will have serial blood samples taken to develop the PD profile.
Time frame: at least 60 days, and up to 6 months
To screen for the development of antibodies against KHK2866 (immunogenicity).
Participants will have serial blood samples to check for the development of anti-KHK2866 antibodies.
Time frame: at least 60 days and up to 6 months
To describe any anti-tumor activity observed when KHK2866 is administered i.v. as monotherapy, or in combination with chemotherapy.
Time frame: at least 60 days and up to 6 months
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Combination chemotherapy with KHK2866 to treat advanced platinum-resistant ovarian cancer. PLD will be administered weekly at a dose of 40 mg/m2.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Oncology Consultants
Houston, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States