A Study of KK2269 in Adult Participants With Solid Tumors
Start Date
1/18/2024
Completion Date
3/1/2029
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
KK2269
Docetaxel
Conditions
Locations
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States
City Of Hope National Medical Center
Duarte, California 91010
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Washington University
St Louis, Missouri 63110
United States
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
University of Washington
Seattle, Washington 98195
United States
Aichi Cancer Center
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo 135-8550
Japan