Actively Recruiting
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
Led by Kyowa Kirin Co., Ltd. · Updated on 2026-03-18
189
Participants Needed
13
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer type). In Part 1b and Part 2, at least two dosing regimens and two dosing regimens by cancer type, respectively, will be selected, and the safety, tolerability, and efficacy of each regimen will be evaluated.
CONDITIONS
Official 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 consent.
- Patients who are refractory to, intolerant of, have no standard treatment, or have refused standard treatment.
- Patients with measurable disease according to RECIST version 1.1.
- Patients who have observed required time intervals since prior therapies.
- Subjects who agree to have a tumor biopsy at baseline or provide a stored tumor specimen.
- Patients with an ECOG Performance Status of 0 or 1 at baseline.
- Patients with adequate hematopoietic, liver, kidney, heart, and lung function based on baseline tests.
- Patients with pathologically diagnosed advanced or metastatic solid tumors (Part 1a).
- Patients with advanced or metastatic esophageal or head and neck squamous cell carcinoma who agree to tumor biopsy after treatment (Parts 1b and 2).
You will not qualify if you...
- Patients with untreated or symptomatic central nervous system metastases requiring treatment.
- Patients with multiple or synchronous cancers diagnosed within the last 5 years or iatrogenic cancers.
- Patients on continuous systemic steroids or other immunosuppressive treatments.
- Patients with prior severe allergic reactions to antibody agents or study drug additives.
- Patients who have not recovered to mild or no adverse events from previous anticancer therapies.
- Patients with active or history of active interstitial lung disease.
- Patients with infections needing systemic treatment.
- Patients with fever of 38.0°C or higher at registration.
- Patients positive for Hepatitis B surface antigen or antibody, Hepatitis C antibody, or HIV antibody in baseline tests.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 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
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan, 734-8551
Not Yet Recruiting
4
Kobe University Hospital
Kobe, Hyōgo, Japan, 650-0017
Actively Recruiting
5
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
6
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan, 860-8556
Not Yet Recruiting
7
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Not Yet Recruiting
8
Saitama Cancer Center
Shinden, Saitama, Japan, 362-0806
Actively Recruiting
9
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan, 411-8777
Actively Recruiting
10
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
11
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
12
Kyushu Cancer Center
Fukuoka, Japan, 811-1347
Actively Recruiting
13
Osaka International Cancer Institute
Osaka, Japan, 540-0008
Actively Recruiting
Research Team
K
Kyowa Kirin Co., Ltd.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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