Actively Recruiting
A Phase 1, Uncontrolled, Open-label, Non-randomized, Dose-escalation Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors Followed by an Uncontrolled, Non-randomized and Randomized Study in Esophageal and Head and Neck Squamous Cell Carcinoma
Led by Kyowa Kirin Co., Ltd. · Updated on 2026-05-27
189
Participants Needed
14
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying KK2260 in patients with advanced or metastatic solid tumors to evaluate its safety, tolerability, and effectiveness. This is a first-in-human, phase 1 clinical trial that aims to determine the maximum tolerated dose (MTD) and assess different dosing regimens. The study focuses on patients with various solid tumors, including esophageal squamous cell carcinoma and head and neck squamous cell carcinoma. KK2260 will be given intravenously at several dose levels. In Part 1a, the maximum tolerated dose will be identified while monitoring safety. Parts 1b and 2 will test at least two dosing regimens for different cancer types to evaluate the safety, tolerability, and efficacy of each regimen. The study is open-label, non-randomized in early parts, and randomized in the later part, with participants assigned to different dosing groups. Participants will undergo weekly laboratory tests for blood counts, liver and kidney function, and other measures for about one year. Researchers will monitor adverse events, vital signs, ECG parameters, and performance status regularly. Various outcomes such as dose-limiting toxicity, overall response rate, progression-free survival, and overall survival will be tracked during treatment and follow-up. The study includes tumor biopsies before and after treatment. The total duration of involvement may last around one year or more depending on treatment and follow-up.
CONDITIONS
Brief Title
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have given informed written consent.
- Male or female subjects 18 years of age or older at the time of signing informed consent.
- Patients refractory to, intolerant of, without standard treatment options, or who have refused standard treatment.
- Patients with measurable disease according to RECIST version 1.1.
- Patients who have observed required periods between prior therapy completion and enrollment.
- Patients who agree to tumor biopsy at baseline or provide previously collected stored specimens.
- Patients with Eastern Cooperative Oncology Group performance status of 0 or 1 at baseline.
- Patients with adequate hematopoietic, hepatic, renal, cardiac, and respiratory function per baseline tests.
- Patients with pathologically diagnosed advanced or metastatic solid tumors (Part 1a).
- Patients with pathologically diagnosed advanced or metastatic esophageal or head and neck squamous cell carcinoma who agree to tumor biopsy after administration (Parts 1b and 2).
You will not qualify if you...
- Patients with untreated or symptomatic central nervous system or brain pia mater metastases requiring treatment.
- Patients with concurrent or synchronous multiple cancers with a disease-free interval of 5 years or less.
- Patients receiving continuous systemic steroids or other immunosuppressive drugs.
- Patients with history of Grade 3 or higher allergic reactions to antibody agents or study drug additives.
- Patients who have not recovered to Grade 1 or below from adverse events of prior anticancer therapy.
- Patients with active interstitial lung disease or history of it.
- Patients with infectious diseases requiring systemic treatment.
- Patients with fever of 38.0°C or higher at registration.
- Patients positive for Hepatitis B antigen or antibody, Hepatitis C antibody, or HIV antibody at baseline.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive intravenous KK2260 at several dose levels in repeated 28-day cycles.
Weekly visits for assessments during each cycle
Duration - Approximately up to 1 year
Participants are monitored for safety and treatment outcomes after treatment completion.
Visits every 12 weeks for up to 1 year
Trial Site Locations
Total: 14 locations
1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
2
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
3
Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Actively Recruiting
4
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan, 734-8551
Actively Recruiting
5
Kobe University Hospital
Kobe, Hyōgo, Japan, 650-0017
Actively Recruiting
6
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
7
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan, 860-8556
Actively Recruiting
8
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
9
Saitama Cancer Center
Shinden, Saitama, Japan, 362-0806
Actively Recruiting
10
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan, 411-8777
Actively Recruiting
11
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
12
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
13
Kyushu Cancer Center
Fukuoka, Japan, 811-1347
Actively Recruiting
14
Osaka International Cancer Institute
Osaka, Japan, 540-0008
Actively Recruiting
Research Team
K
Kyowa Kirin Co., Ltd.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here