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

Phase 1RecruitingNCT06248411

Kyowa Kirin Co., Ltd.189 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

189

Conditions

Advanced or Metastatic Solid Tumors

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \<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.

Locations (14)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Outcomes

Primary Outcomes

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

Central Contacts

Kyowa Kirin Co., Ltd.

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Shikoku Cancer Center

Matsuyama, Ehime, Japan

RECRUITING

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

RECRUITING

Kobe University Hospital

Kobe, Hyōgo, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

RECRUITING

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, Japan

RECRUITING

Saitama Cancer Center

Shinden, Saitama, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

RECRUITING

...and 4 more locations

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)

Prothrombin time international normalized ratio and Activated partial thromboplastin time

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

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)

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

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

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)