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

Advanced or Metastatic Solid Tumors Clinical Trial

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, Randomized Study in Patients With Esophageal Cancer or Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248411
• Other study ID #: 2260-001
• Status: Recruiting
• Phase: Phase 1
• Start date: October 10, 2023
• Est. completion date: May 31, 2029

Study information

• Verified date: February 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: Kyowa Kirin Co., Ltd.
• Phone: +81-80-7326-3828
• Email: clinical.info.jp[@]kyowakirin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the first in human study of KK2260. In Part 1, 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). Part 2 will compare the safety and tolerability of KK2260 in patients with multiple cancer types in multiple dose regimen arms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 139
• Est. completion date: May 31, 2029
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

<Common Inclusion Criteria to Part 1 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 certain 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 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>

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.

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• KK2260
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
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.

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East	Kashiwa city	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (Only part 1)		During the first cycle (1 Cycle = 28 days)
Primary	Adverse Events		Through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Red blood cell count)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Hemoglobin concentration)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Hematocrit)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Reticulocyte)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Mean corpuscular volume)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Mean corpuscular hemoglobin)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Mean corpuscular hemoglobin concentration)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (White blood cell count)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Differential white blood cells (basophils, eosinophils, lymphocytes, monocytes, neutrophils))		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Platelet count)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Total protein)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Albumin)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Alkaline phosphatase)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Alanine aminotransferase/Aspartate aminotransferase)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Total bilirubin/Direct bilirubin)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Blood urea nitrogen)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Calcium/Corrected Calcium)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Chloride)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Potassium)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Sodium)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Magnesium)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Serum iron)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Ferritin)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Total iron binding capacity)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Unsaturated iron binding capacity)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Serum creatinine)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Creatinine clearance (Cockgroft-gault formula))		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Lactate dehydrogenase)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Blood glucose)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Uric acid)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Lipase)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Amylase)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (C-reactive protein)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Gamma-glutamyl transpeptidase)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Triglycerides)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Cholesterol)		Every week through study completion, an average of 1 year
Primary	Changes in Laboratory Testing Values (Creatine phosphokinase)		Every week through study completion, an average of 1 year
Primary	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
Primary	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)
Primary	Changes in Body temperature (degree Celsius)		Every week through study completion, an average of 1 year
Primary	Changes in Systolic and Diastolic Blood Pressure (mmHg)		Every week through study completion, an average of 1 year
Primary	Changes in SpO2 (%)		Every week through study completion, an average of 1 year
Primary	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
Primary	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	Serum concentration levels of KK2260		Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Secondary	Maximum Plasma Concentration (Cmax)		Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Secondary	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)
Secondary	Anti-drug antibody		Pre-dose and post-dose at multiple timepoints for each cycle during the intervention (each cycle is 28 days)
Secondary	Overall Response Rate (Only part 2)		During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Secondary	Disease control rate (Only part 2)		During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Secondary	Duration Of Response (Only part 2)		During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Secondary	Progression-free survival (Only part 2)		During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Secondary	Overall Survival (Only part 2)		During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)
Secondary	Time To Response (Only part 2)		During the treatment and every 12 weeks after study treatment completion (approximately up to 1 year)