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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Mayo Clinic Arizona
Scottsdale, Arizona, United States
RECRUITINGCity Of Hope National Medical Center
Duarte, California, United States
RECRUITINGHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGThe University of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITINGAichi Cancer Center
Nagoya, Aichi-ken, Japan
RECRUITINGNational Cancer Center Hospital East
Kashiwa, Chiba, Japan
RECRUITINGNational Cancer Center Hospital
Chuo-ku, Tokyo, Japan
RECRUITING...and 1 more locations
Number of Subjects Experiencing Dose-limiting Toxicity
Time frame: 21 days after first dose
Number of Adverse Events
Time frame: From signing of ICF through study completion, an average of 1 year
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