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RecruitingNCT06248411Updated May 27, 2026

A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors

A Phase 1 interventional study of KK2260 and KK2260 in Advanced or Metastatic Solid Tumors, sponsored by Kyowa Kirin Co., Ltd.. Recruiting at 14 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Advanced or Metastatic Solid Tumors
03

In context

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

\<Common Inclusion Criteria for Part 1a, Part 1b, and Part 2

  1. Patients who have given informed written consent.
  2. Male or female subjects ≥18 years of age, at time of signing informed consent.
  3. Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment.
  4. Patients with measurable disease according to RECIST version 1.1
  5. Patients who have had the certaion periods between the date of completion of prior therapy and the date of enrollment
  6. 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.
  7. Patients with an ECOG PS of 0 or 1 at baseline.
  8. 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

  1. 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.
  2. Patients with pathologically diagnosed squamous cell carcinoma.
  3. Patients who agree to undergo tumor biopsy after administration.

\<Additional Inclusion Criteria for Part 2a

  1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer.
  2. Patients with pathologically diagnosed squamous cell carcinoma.
  3. Patients who agree to undergo tumor biopsy after administration.

\<Additional Inclusion Criteria for Part 2b

  1. 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.
  2. Patients with pathologically diagnosed squamous cell carcinoma.
  3. Patients who agree to undergo tumor biopsy after administration.

Exclusion criteria

Exclusion Criteria:

\<Common Exclusion Criteria to Part 1 and Part 2>

  1. Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.
  2. Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.
  3. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.
  4. Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.
  5. Patients who have not recovered to Grade 1 or below from adverse events caused by previously administered anticancer therapy.
  6. Patients with active interstitial lung disease or a history of active interstitial lung disease.
  7. Patients with infectious diseases requiring systemic treatment.
  8. Patients with a fever of 38.0°C or higher at the time of registration.
  9. Patients who test positive for Hepatitis B virus antigen or antibody, Hepatitis C virus antibody, or HIV antibody in a baseline test.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
189 participants (estimated)

Study arms

  • Experimental
    KK2260 (Dosing regimen 1)

    Drug: KK2260

  • Experimental
    KK2260 (Dosing regimen 2)

    Drug: KK2260

Interventions

  • DrugKK2260

    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.

  • DrugKK2260

    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.

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity (Only in Part 1a)

    Time frame: During the first cycle (1 Cycle = 28 days)

  2. Adverse Events

    Time frame: Through study completion, an average of 1 year

  3. Changes in Laboratory Testing Values (Red blood cell count)

    Time frame: Every week through study completion, an average of 1 year

  4. Changes in Laboratory Testing Values (Hemoglobin concentration)

    Time frame: Every week through study completion, an average of 1 year

  5. Changes in Laboratory Testing Values (Hematocrit)

    Time frame: Every week through study completion, an average of 1 year

  6. Changes in Laboratory Testing Values (Reticulocyte)

    Time frame: Every week through study completion, an average of 1 year

  7. Changes in Laboratory Testing Values (Mean corpuscular volume)

    Time frame: Every week through study completion, an average of 1 year

  8. Changes in Laboratory Testing Values (Mean corpuscular hemoglobin)

    Time frame: Every week through study completion, an average of 1 year

  9. Changes in Laboratory Testing Values (Mean corpuscular hemoglobin concentration)

    Time frame: Every week through study completion, an average of 1 year

  10. Changes in Laboratory Testing Values (White blood cell count)

    Time frame: Every week through study completion, an average of 1 year

  11. 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

  12. Changes in Laboratory Testing Values (Platelet count)

    Time frame: Every week through study completion, an average of 1 year

  13. Changes in Laboratory Testing Values (Total protein)

    Time frame: Every week through study completion, an average of 1 year

  14. Changes in Laboratory Testing Values (Albumin)

    Time frame: Every week through study completion, an average of 1 year

  15. Changes in Laboratory Testing Values (Alkaline phosphatase)

    Time frame: Every week through study completion, an average of 1 year

  16. Changes in Laboratory Testing Values (Alanine aminotransferase/Aspartate aminotransferase)

    Time frame: Every week through study completion, an average of 1 year

  17. Changes in Laboratory Testing Values (Total bilirubin/Direct bilirubin)

    Time frame: Every week through study completion, an average of 1 year

  18. Changes in Laboratory Testing Values (Blood urea nitrogen)

    Time frame: Every week through study completion, an average of 1 year

  19. Changes in Laboratory Testing Values (Calcium/Corrected Calcium)

    Time frame: Every week through study completion, an average of 1 year

  20. Changes in Laboratory Testing Values (Chloride)

    Time frame: Every week through study completion, an average of 1 year

  21. Changes in Laboratory Testing Values (Potassium)

    Time frame: Every week through study completion, an average of 1 year

  22. Changes in Laboratory Testing Values (Sodium)

    Time frame: Every week through study completion, an average of 1 year

  23. Changes in Laboratory Testing Values (Magnesium)

    Time frame: Every week through study completion, an average of 1 year

  24. Changes in Laboratory Testing Values (Serum iron)

    Time frame: Every week through study completion, an average of 1 year

  25. Changes in Laboratory Testing Values (Ferritin)

    Time frame: Every week through study completion, an average of 1 year

  26. Changes in Laboratory Testing Values (Total iron binding capacity)

    Time frame: Every week through study completion, an average of 1 year

  27. Changes in Laboratory Testing Values (Unsaturated iron binding capacity)

    Time frame: Every week through study completion, an average of 1 year

  28. Changes in Laboratory Testing Values (Serum creatinine)

    Time frame: Every week through study completion, an average of 1 year

  29. Changes in Laboratory Testing Values (Creatinine clearance (Cockcroft-Gault formula))

    Time frame: Every week through study completion, an average of 1 year

  30. Changes in Laboratory Testing Values (Lactate dehydrogenase)

    Time frame: Every week through study completion, an average of 1 year

  31. Changes in Laboratory Testing Values (Blood glucose)

    Time frame: Every week through study completion, an average of 1 year

  32. Changes in Laboratory Testing Values (Uric acid)

    Time frame: Every week through study completion, an average of 1 year

  33. Changes in Laboratory Testing Values (Lipase)

    Time frame: Every week through study completion, an average of 1 year

  34. Changes in Laboratory Testing Values (Amylase)

    Time frame: Every week through study completion, an average of 1 year

  35. Changes in Laboratory Testing Values (C-reactive protein)

    Time frame: Every week through study completion, an average of 1 year

  36. Changes in Laboratory Testing Values (Gamma-glutamyl transpeptidase)

    Time frame: Every week through study completion, an average of 1 year

  37. Changes in Laboratory Testing Values (Triglycerides)

    Time frame: Every week through study completion, an average of 1 year

  38. Changes in Laboratory Testing Values (Cholesterol)

    Time frame: Every week through study completion, an average of 1 year

  39. Changes in Laboratory Testing Values (Creatine phosphokinase)

    Time frame: Every week through study completion, an average of 1 year

  40. Changes in Laboratory Testing Values (Coagulation test)

    Prothrombin time international normalized ratio and Activated partial thromboplastin time

    Time frame: Every week through study completion, an average of 1 year

  41. 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)

  42. Changes in Body temperature (degree Celsius)

    Time frame: Every week through study completion, an average of 1 year

  43. Changes in Systolic and Diastolic Blood Pressure (mmHg)

    Time frame: Every week through study completion, an average of 1 year

  44. Changes in SpO2 (%)

    Time frame: Every week through study completion, an average of 1 year

  45. 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.

    Time frame: Every week through study completion, an average of 1 year

  46. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Anti-drug antibody

    Time frame: Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. Overall Survival (in Part 1b/2)

    Time frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)

  10. 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)

07

Study locations

14 of 14 sites recruiting
  • Aichi Cancer Center Hospital
    Nagoya, Aichi-ken 464-8681, Japan
    Recruiting
  • National Cancer Center Hospital East
    Kashiwa, Chiba 277-8577, Japan
    Recruiting
  • Shikoku Cancer Center
    Matsuyama, Ehime 791-0280, Japan
    Recruiting
  • Hiroshima University Hospital
    Hiroshima, Hiroshima 734-8551, Japan
    Recruiting
  • Kobe University Hospital
    Kobe, Hyōgo 650-0017, Japan
    Recruiting
  • Kanagawa Cancer Center
    Yokohama, Kanagawa 241-8515, Japan
    Recruiting
  • Kumamoto University Hospital
    Kumamoto, Kumamoto 860-8556, Japan
    Recruiting
  • Tohoku University Hospital
    Sendai, Miyagi 980-8574, Japan
    Recruiting
  • Saitama Cancer Center
    Shinden, Saitama 362-0806, Japan
    Recruiting
  • Shizuoka Cancer Center
    Nagaizumi-cho, Shizuoka 411-8777, Japan
    Recruiting
  • National Cancer Center Hospital
    Chuo-ku, Tokyo 104-0045, Japan
    Recruiting
  • The Cancer Institute Hospital of JFCR
    Koto-ku, Tokyo 135-8550, Japan
    Recruiting
  • Kyushu Cancer Center
    Fukuoka, 811-1347, Japan
    Recruiting
  • Osaka International Cancer Institute
    Osaka, 540-0008, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06248411
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Feb 8, 2024
Start date
Nov 1, 2023
Primary completion
Oct 31, 2029 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
May 27, 2026

Study contacts

Kyowa Kirin Co., Ltd.
Contact
clinical.info.jp@kyowakirin.com
+81-3-5205-7200

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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