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

NCT06248411 | Recruiting Phase 1

• 1 other identifier: 2260-001
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (46)

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

  During the first cycle (1 Cycle = 28 days)

• Adverse Events

  Through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Red blood cell count)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Hemoglobin concentration)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Hematocrit)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Reticulocyte)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Mean corpuscular volume)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Mean corpuscular hemoglobin)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Mean corpuscular hemoglobin concentration)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (White blood cell count)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Differential white blood cells (basophils, eosinophils, lymphocytes, monocytes, neutrophils))

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Platelet count)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Total protein)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Albumin)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Alkaline phosphatase)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Alanine aminotransferase/Aspartate aminotransferase)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Total bilirubin/Direct bilirubin)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Blood urea nitrogen)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Calcium/Corrected Calcium)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Chloride)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Potassium)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Sodium)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Magnesium)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Serum iron)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Ferritin)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Total iron binding capacity)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Unsaturated iron binding capacity)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Serum creatinine)

  Every week through study completion, an average of 1 year

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

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Lactate dehydrogenase)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Blood glucose)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Uric acid)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Lipase)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Amylase)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (C-reactive protein)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Gamma-glutamyl transpeptidase)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Triglycerides)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Cholesterol)

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Creatine phosphokinase)

  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

  Every week through study completion, an average of 1 year

• Changes in Laboratory Testing Values (Hepatitis B virus DNA, if needed)

  Every 2 cycle through study completion, an average of 1 year (1 Cycle = 28 days)

• Changes in Body temperature (degree Celsius)

  Every week through study completion, an average of 1 year

• Changes in Systolic and Diastolic Blood Pressure (mmHg)

  Every week through study completion, an average of 1 year

• Changes in SpO2 (%)

  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.

  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.)

  Every week through study completion, an average of 1 year

Secondary Outcomes (10)

• Serum concentration levels of KK2260

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

• Maximum Plasma Concentration (Cmax)

  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)

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

• Anti-drug antibody

  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)

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

Study Arms (2)

KK2260 (Dosing regimen 1)

EXPERIMENTAL

Drug: KK2260

KK2260 (Dosing regimen 2)

EXPERIMENTAL

Drug: KK2260

Interventions

KK2260 DRUG

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.

KK2260 (Dosing regimen 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• \) Patients with pathologically diagnosed advanced or metastatic solid tumors.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (14)

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

Central Study Contacts

Kyowa Kirin Co., Ltd.

CONTACT

+81-3-5205-7200; clinical.info.jp@kyowakirin.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: February 8, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (14)