- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06248411
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
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, Randomized Study in Patients With Esophageal Cancer or Head and Neck Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Kyowa Kirin Co., Ltd.
- Phone Number: +81-80-7326-3828
- Email: clinical.info.jp@kyowakirin.com
Study Locations
-
-
Chiba
-
Kashiwa city, Chiba, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
-
-
Tokyo
-
Chuo-ku, Tokyo, Japan, 104-0045
- Recruiting
- National Cancer Center Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
<Common Inclusion Criteria to Part 1 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 certain 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.
<Additional Inclusion Criteria for Part 1> 1) Patients with pathologically diagnosed advanced or metastatic solid tumors.
<Additional Inclusion Criteria for Part 2a>
1) Patients with pathologically diagnosed with advanced or metastatic esophageal cancer.
<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.
Exclusion Criteria:
<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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KK2260 (Dosing regimen 1)
|
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.
|
Experimental: KK2260 (Dosing regimen 2)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity (Only part 1)
Time Frame: During the first cycle (1 Cycle = 28 days)
|
During the first cycle (1 Cycle = 28 days)
|
|
Adverse Events
Time Frame: Through study completion, an average of 1 year
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Every week through study completion, an average of 1 year
|
|
Changes in Laboratory Testing Values (Creatinine clearance (Cockgroft-gault formula))
Time Frame: Every week through study completion, an average of 1 year
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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)
|
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
|
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
|
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
|
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.
|
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
|
Every week through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
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)
|
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)
|
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)
|
Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
|
Overall Response Rate (Only part 2)
Time Frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
Disease control rate (Only part 2)
Time Frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
Duration Of Response (Only part 2)
Time Frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
Progression-free survival (Only part 2)
Time Frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
Overall Survival (Only part 2)
Time Frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
Time To Response (Only part 2)
Time Frame: During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2260-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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