Actively Recruiting
A Study of KK2269 in Adult Participants With Solid Tumors
Led by Kyowa Kirin Co., Ltd. · Updated on 2026-01-28
101
Participants Needed
11
Research Sites
267 weeks
Total Duration
On this page
Sponsors
K
Kyowa Kirin Co., Ltd.
Lead Sponsor
K
Kyowa Kirin, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of KK2269 in Adult Participants With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older at the time of informed consent
- Patients with measurable disease by RECIST v1.1
- Patients with an ECOG performance status of 0 or 1
- Patients with a life expectancy of at least 3 months as judged by the investigator
- Specified time periods have passed since completion of prior cancer treatments
- Patients agree to use medically effective contraception
- Part 1: Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor
- Part 2: Patients with histological or cytological evidence of gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, esophageal adenocarcinoma, or non-small cell lung cancer
- Part 2: Patients suitable for docetaxel treatment
You will not qualify if you...
- Patients with an uncontrolled or serious intercurrent illness
- Patients with known active central nervous system metastasis
- Patients with a history of grade 3 or higher allergic reaction to any antibody drug
- Patients with a history of autoimmune disease
- Patients with a history of HIV, hepatitis B, or hepatitis C at screening
- Patients with a history of primary immunodeficiency
- Part 2: Patients with a history of treatment with docetaxel
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
City Of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
6
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
7
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
8
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
9
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
10
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
11
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
K
Kyowa Kirin Co., Ltd.
CONTACT
K
Kyowa Kirin, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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