This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.
In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.
In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.
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
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
Sequential
KK2269
DrugKK2269 administered intravenously
Docetaxel
Drugantineoplastic drug administered intravenously
Number of Subjects Experiencing Dose-limiting Toxicity
Number of Adverse Events
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Kyowa Kirin Co., Ltd.
Lead sponsor
Kyowa Kirin, Inc.
Collaborator
