Advanced or Metastatic Solid TumorsPhase 1NCT06248411
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing KK2260 in people with Advanced or Metastatic Solid Tumors, run by Kyowa Kirin Co., Ltd. at 14 sites in Japan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- KK2260
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 14 sitesJapan
- Study dates
- 1 Nov 2023to 30 Apr 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- <Common Inclusion Criteria for Part 1a, Part 1b, and Part 2
- Patients who have given informed written consent.
- Male or female subjects ≥18 years of age, at time of signing informed consent.
- Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment.
- Patients with measurable disease according to RECIST version 1.1
- Patients who have had the certaion periods between the date of completion of prior therapy and the date of enrollment
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- Subjects who agree to have a tumor biopsy as part of the baseline examination. Patients who have difficulty in performing a tumour biopsy and have agreed to submit a previously collected stored specimen.
- Patients with an ECOG PS of 0 or 1 at baseline.
- Patients with haematopoietic, hepatic, renal, cardiac and respiratory functions that meet certain criteria in a baseline test.
- <Additional Inclusion Criteria for Part 1a
- 1) Patients with pathologically diagnosed advanced or metastatic solid tumors.
- <Additional Inclusion Criteria for Part 1b
- Patients with pathologically diagnosed with advanced or metastatic esophageal cancer, or advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses.
- Patients with pathologically diagnosed squamous cell carcinoma.
- Patients who agree to undergo tumor biopsy after administration.
- <Additional Inclusion Criteria for Part 2a
- Patients with pathologically diagnosed with advanced or metastatic esophageal cancer.
- Patients with pathologically diagnosed squamous cell carcinoma.
- Patients who agree to undergo tumor biopsy after administration.
- <Additional Inclusion Criteria for Part 2b
- Patients with advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses.
- Patients with pathologically diagnosed squamous cell carcinoma.
- Patients who agree to undergo tumor biopsy after administration.
Who cannot join
- <Common Exclusion Criteria to Part 1 and Part 2>
- Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.
- Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.
- Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.
- Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.
- Patients who have not recovered to Grade 1 or below from adverse events caused by previously administered anticancer therapy.
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- Patients with active interstitial lung disease or a history of active interstitial lung disease.
- Patients with infectious diseases requiring systemic treatment.
- Patients with a fever of 38.0°C or higher at the time of registration.
- Patients who test positive for Hepatitis B virus antigen or antibody, Hepatitis C virus antibody, or HIV antibody in a baseline test.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Japan14 sites, 14 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
Kyushu Cancer Center
Fukuoka, 811-1347
- Recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Kobe University Hospital
Kobe, Hyōgo, 650-0017
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
- Recruiting
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
- Recruiting
Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
- Recruiting
Osaka International Cancer Institute
Osaka, 540-0008
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
- Recruiting
Saitama Cancer Center
Shinden, Saitama, 362-0806
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
About this study
Official title: 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 Study and an Uncontrolled, Randomized Study in Patients With Esophageal Squamous Cell Carcinoma or Head and Neck Squamous Cell Carcinoma
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
- Advanced or Metastatic Solid Tumors
- Being tested
- KK2260
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KK2260Drug
KK2260 will be administered intravenously at several dose levels, and after determining MTD, multiple dose regimens will be evaluated in multiple cancer types to target.
KK2260Drug
KK2260 will be administered intravenously at several dose levels, and after determining MTD, multiple dose regimens will be evaluated in multiple cancer types to target.
| Study group | Role | What they receive |
|---|---|---|
| KK2260 (Dosing regimen 1) | Experimental | Not described Receives: Drug: KK2260 |
| KK2260 (Dosing regimen 2) | Experimental | Not described Receives: Drug: KK2260 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (Only in Part 1a)
Measured: During the first cycle (1 Cycle = 28 days)
Adverse Events
Measured: Through study completion, an average of 1 year
Changes in Laboratory Testing Values (Red blood cell count)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Hemoglobin concentration)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Hematocrit)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Reticulocyte)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Mean corpuscular volume)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Mean corpuscular hemoglobin)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Mean corpuscular hemoglobin concentration)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (White blood cell count)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Differential white blood cells (basophils, eosinophils, lymphocytes, monocytes, neutrophils))
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Platelet count)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Total protein)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Albumin)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Alkaline phosphatase)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Alanine aminotransferase/Aspartate aminotransferase)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Total bilirubin/Direct bilirubin)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Blood urea nitrogen)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Calcium/Corrected Calcium)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Chloride)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Potassium)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Sodium)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Magnesium)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Serum iron)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Ferritin)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Total iron binding capacity)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Unsaturated iron binding capacity)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Serum creatinine)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Creatinine clearance (Cockcroft-Gault formula))
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Lactate dehydrogenase)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Blood glucose)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Uric acid)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Lipase)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Amylase)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (C-reactive protein)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Gamma-glutamyl transpeptidase)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Triglycerides)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Cholesterol)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Creatine phosphokinase)
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Coagulation test)
Prothrombin time international normalized ratio and Activated partial thromboplastin time
Measured: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Hepatitis B virus DNA, if needed)
Measured: Every 2 cycle through study completion, an average of 1 year (1 Cycle = 28 days)
Changes in Body temperature (degree Celsius)
Measured: Every week through study completion, an average of 1 year
Changes in Systolic and Diastolic Blood Pressure (mmHg)
Measured: Every week through study completion, an average of 1 year
Changes in SpO2 (%)
Measured: Every week through study completion, an average of 1 year
Changes in Electrocardiogram parameters (Heart rate, PR interval, QRS interval, QT interval, and QTc intervals)
The resting Heart rate, PR interval, QRS interval, QT interval, and QTc intervals will be recorded. Any abnormalities in ECG will be specified and documented as clinically significant or not clinically significant.
Measured: Every week through study completion, an average of 1 year
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS) (The score should be 0 to 4, and the lower is the better.)
Measured: Every week through study completion, an average of 1 year
Secondary outcomes (10)
Serum concentration levels of KK2260
Measured: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Maximum Plasma Concentration (Cmax)
Measured: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Area Under the blood concentration-time Curve (AUC)
Measured: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Anti-drug antibody
Measured: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Overall Response Rate (in Part 1b/2)
Measured: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Disease Control Rate (in Part 1b/2)
Measured: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Duration of Response (in Part 1b/2)
Measured: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Progression-Free Survival (in Part 1b/2)
Measured: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Overall Survival (in Part 1b/2)
Measured: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Time to Response (in Part 1b/2)
Measured: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Nov 2023
- Primary completion31 Oct 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248411
- Sponsor's protocol ID
- 2260-001
- Status last verified
- May 2026
- First submitted
- 26 Sep 2023
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Study and an Uncontrolled, Randomized Study in Patients With Esophageal Squamous Cell Carcinoma or Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06248411
- Acronym / sponsor ID
- 2260-001
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KK2260 (Dosing regimen 1) | Experimental | Drug: KK2260 |
| KK2260 (Dosing regimen 2) | Experimental | Drug: KK2260 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- <Common Inclusion Criteria for Part 1a, Part 1b, and Part 2
- Patients who have given informed written consent.
- Male or female subjects ≥18 years of age, at time of signing informed consent.
- Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment.
- Patients with measurable disease according to RECIST version 1.1
Key exclusion criteria (10 listed)
- <Common Exclusion Criteria to Part 1 and Part 2>
- Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.
- Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.
- Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.
- Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KK2260KK2260 will be administered intravenously at several dose levels, and after determining MTD, multiple dose regimens will be evaluated in multiple cancer types to target. | Drug | KK2260 (Dosing regimen 1) |
| KK2260KK2260 will be administered intravenously at several dose levels, and after determining MTD, multiple dose regimens will be evaluated in multiple cancer types to target. | Drug | KK2260 (Dosing regimen 2) |
Primary outcome
Dose-limiting toxicity (Only in Part 1a)
Time frame: During the first cycle (1 Cycle = 28 days)
Adverse Events
Time frame: Through study completion, an average of 1 year
Changes in Laboratory Testing Values (Red blood cell count)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Hemoglobin concentration)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Hematocrit)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Reticulocyte)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Mean corpuscular volume)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Mean corpuscular hemoglobin)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Mean corpuscular hemoglobin concentration)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (White blood cell count)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Differential white blood cells (basophils, eosinophils, lymphocytes, monocytes, neutrophils))
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Platelet count)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Total protein)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Albumin)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Alkaline phosphatase)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Alanine aminotransferase/Aspartate aminotransferase)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Total bilirubin/Direct bilirubin)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Blood urea nitrogen)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Calcium/Corrected Calcium)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Chloride)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Potassium)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Sodium)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Magnesium)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Serum iron)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Ferritin)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Total iron binding capacity)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Unsaturated iron binding capacity)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Serum creatinine)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Creatinine clearance (Cockcroft-Gault formula))
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Lactate dehydrogenase)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Blood glucose)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Uric acid)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Lipase)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Amylase)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (C-reactive protein)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Gamma-glutamyl transpeptidase)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Triglycerides)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Cholesterol)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Creatine phosphokinase)
Time frame: Every week through study completion, an average of 1 year
Changes in Laboratory Testing Values (Coagulation test)
Time frame: Every week through study completion, an average of 1 year
Prothrombin time international normalized ratio and Activated partial thromboplastin time
Changes in Laboratory Testing Values (Hepatitis B virus DNA, if needed)
Time frame: Every 2 cycle through study completion, an average of 1 year (1 Cycle = 28 days)
Changes in Body temperature (degree Celsius)
Time frame: Every week through study completion, an average of 1 year
Changes in Systolic and Diastolic Blood Pressure (mmHg)
Time frame: Every week through study completion, an average of 1 year
Changes in SpO2 (%)
Time frame: Every week through study completion, an average of 1 year
Changes in Electrocardiogram parameters (Heart rate, PR interval, QRS interval, QT interval, and QTc intervals)
Time frame: Every week through study completion, an average of 1 year
The resting Heart rate, PR interval, QRS interval, QT interval, and QTc intervals will be recorded. Any abnormalities in ECG will be specified and documented as clinically significant or not clinically significant.
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS) (The score should be 0 to 4, and the lower is the better.)
Time frame: Every week through study completion, an average of 1 year
10 secondary outcomes
Serum concentration levels of KK2260
Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Area Under the blood concentration-time Curve (AUC)
Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Anti-drug antibody
Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Overall Response Rate (in Part 1b/2)
Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Disease Control Rate (in Part 1b/2)
Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Duration of Response (in Part 1b/2)
Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Progression-Free Survival (in Part 1b/2)
Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Overall Survival (in Part 1b/2)
Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Time to Response (in Part 1b/2)
Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KK2260 in people with Advanced or Metastatic Solid Tumors, run by Kyowa Kirin Co., Ltd. at 14 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyowa Kirin Co., Ltd. (+81-3-5205-7200, clinical.info.jp@kyowakirin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (Only in Part 1a) (time frame: During the first cycle (1 Cycle = 28 days)). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.