None listed
Conditions
Interventions
KK2269 will be administered at each dose level, intravenous infusion.
KK2269 will be administered at each dose level intravenously in combination with docetaxel.
Docetaxel will be administered intra
Sponsors
Muto Satsuki
Eligibility
Inclusion criteria
Inclusion criteria: -Patients who are >= 18 years old at the time of informed consent -Patients who have disease measurable by RECIST v1.1 -Patients with an ECOG PS of 0 or 1 -Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator -The specified periods have passed respectively after the completion of the cancer treatments at the time of the first dose of KK2269 -Patients who agree to use a medically effective method of contraception -Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor -Patients with histological or cytological evidence of any of the following disease - Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma - NSCLC -Only patients with NSCLC will be enrolled in the expansion part. -Patients who are suitable for docetaxel treatment
Exclusion criteria
Exclusion criteria: -Patients with an uncontrolled or serious intercurrent illness -Patients with known active central nervous system metastasis -Patients with a history of >= Grade 3 allergic reaction to any antibody drug -Patients with a history of autoimmune disease -Patients with a history of HIV, HBV, or HCV at screening -Patients who have a history of primary immunodeficiency -Patients with a history of treatment with docetaxel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - DLTs - AEs - Laboratory test values - Vital signs - ECG parameters - DLTs (dose-escalation part) - AEs - Laboratory test values - Vital signs - ECG parameters | — |
Countries
Japan, United States
Contacts
Public ContactClinical trial information contact
Kyowa Kirin Co., Ltd.
Outcome results
None listed