A Study of KK2269 in Adult Participants With Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Non Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06266299
- Run by
- Kyowa Kirin Co., Ltd.
- People needed
- 101
- Starts
- 2024-01-18
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
- City Of Hope National Medical Center — Duarte, California, United States (enrolling)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- University of Washington — Seattle, Washington, United States (enrolling)
- Aichi Cancer Center — Nagoya, Aichi-ken, Japan (enrolling)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (enrolling)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (enrolling)
- Cancer Institute Hospital of JFCR — Koto-Ku, Tokyo, Japan (enrolling)
Full record on ClinicalTrials.gov
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