Advanced Solid TumorPhase 1NCT06266299
A Study of KK2269 in Adult Participants With Solid Tumors
A Phase 1 study testing KK2269 and Docetaxel in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Kyowa Kirin Co., Ltd. at 32 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma
- What is being tested?
- KK2269 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 18 Jan 2024to Mar 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Key Common Inclusion Criteria for Parts 1 and 2:
- Patients who are ≥ 18 years old at the time of informed consent
- Patients who have disease measurable by RECIST v1.1
- Patients with an ECOG PS of 0 or 1
- Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator
- The specified periods have passed respectively after the completion of previous cancer treatments as of the date of enrollment at the time of the first dose of KK2269
- Patients who agree to use a medically effective method of contraception
- Key Additional Inclusion Criterion for Part 1: •Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor
- Key Additional Inclusion Criteria for Part 2: •Patients with histological or cytological evidence of any of the following disease: Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma, NSCLC (Only patients with NSCLC will be enrolled in the expansion part) •Patients who are suitable for docetaxel treatment
- Key Common Exclusion Criteria for Parts 1 and 2:
- Patients with an uncontrolled or serious intercurrent illness
- Patients with known active central nervous system metastasis
- Patients with a history of ≥ Grade 3 allergic reaction to any antibody drug
- Patients with a history of autoimmune disease
- Patients with a history of HIV, HBV, or HCV at screening
- Patients who have a history of primary immunodeficiency
- Key Additional Exclusion Criterion For Part 2:
- Patients with a history of treatment with docetaxel
Trial locations and contacts
32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 2 countries
Japan25 sites, 25 recruiting
- Recruiting
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, 113-8677
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
- Recruiting
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
- Recruiting
Hiroshima University Hospital
Hiroshima, 734-8551
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Kobe Minimally Invasive Cancer Center
Kobe, Hyōgo, 650-0046
- Recruiting
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, 135-8550
- Recruiting
Kumamoto University Hospital
Kumamoto, 860-8556
- Recruiting
Kurume University Hospital
Kurume, Fukuoka, 830-0011
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
- Recruiting
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, 411-8777
- Recruiting
Nagasaki University Hospital
Nagasaki, 852-8501
- Recruiting
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
- Recruiting
Niigata Cancer Center Hospital
Niigata, 951-8566
- Recruiting
Okayama University Hospital
Okayama, 700-8558
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
- Recruiting
Kindai University Hospital
Sakai, Osaka, 590-0197
- Recruiting
NHO Kinki-Chuo Chest Medical Center
Sakai, Osaka, 591-8555
- Recruiting
Saitama Prefectural Cancer Center
Shinden, Saitama, 362-0806
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, 569-8686
- Recruiting
Toyama University Hospital
Toyama, 930-0194
- Recruiting
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
- Recruiting
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
United States7 sites, 7 recruiting
- Recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
City Of Hope National Medical Center
Duarte, California, 91010
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
- Recruiting
University of Washington
Seattle, Washington, 98195
- Recruiting
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase 1, Multicenter, Open-label, Dose-escalation Study Evaluating the Safety and Tolerability of Intravenous KK2269 Monotherapy and Combination Therapy With Docetaxel in Adult Participants With Solid Tumors
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
- Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Non Small Cell Lung Cancer
- Being tested
- KK2269, Docetaxel
- Medical subject headings
- Neoplasm Metastasis, Adenocarcinoma Of Esophagus, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KK2269Drug
KK2269 administered intravenously
DocetaxelDrug
Also called Docetaxel Hydrate
antineoplastic drug administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | KK2269 will be administered at each dose level, intravenous infusion. Receives: Drug: KK2269 |
| Part 2 | Experimental | KK2269 will be administered at each dose level intravenously in combination with docetaxel.
Docetaxel will be administered intravenously (Q3W). Receives: Drug: KK2269; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing Dose-limiting Toxicity
Measured: 21 days after first dose
Number of Adverse Events
Measured: From signing of ICF through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start18 Jan 2024
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266299
- Sponsor's protocol ID
- 2269-001
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.