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,
Non-randomized Study and an Uncontrolled, Randomized
Study in Patients With Esophageal Squamous Cell Carcinoma or Head and Neck Squamous Cell
Carcinoma
tumors (N=189)
Part 1a: Monotherapy in adults with advanced or metastatic solid tumors (any cancer type)
Primary objective
- To determine the safety, tolerability, and MTD of KK2260
Part 1b: Monotherapy using ≥3 dosing regimens by cancer type
Primary objective
- To determine the safety, tolerability, and efficacy of each KK2260 regimen
Part 2: Monotherapy using 2 dosing regimens in adults with esophageal cancer or head and neck squamous cell cancer
Primary objective
- To determine the safety, tolerability, and efficacy of each KK2260 regimen
Primary Outcome Measures
- Dose-limiting toxicity (only in Part 1a)
- Adverse Events
- Changes in:
- - Laboratory testing values*
- - Body temperature
- - Blood pressure
- - SpO2
- - ECG parameters†
- - ECOG PS‡
*Red blood cell count, hemoglobin concentration, hematocrit, reticulocyte, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, white blood cell count, differential white blood cells (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelet count, total protein, albumin, alkaline phosphatase, alanine aminotransferase/aspartate aminotransferase, total bilirubin/direct bilirubin, blood urea nitrogen, calcium/corrected calcium, chloride, potassium, sodium, magnesium, serum iron, ferritin, total iron binding capacity, unsaturated iron binding capacity, serum creatinine, creatinine clearance (Cockcroft-Gault formula), lactate dehydrogenase, blood glucose, uric acid, lipase, amylase, C-reactive protein, gamma-glutamyl transpeptidase, triglycerides, cholesterol, creatine phosphokinase, coagulation test, hepatitis B virus DNA, if needed. †Changes in ECG parameters (heart rate, PR interval, QRS interval, and QTc intervals). ‡Changes in ECOG PS (score should be 0 to 4).
AUC, area under the curve; Cmax, maximum plasma concentration; DCR, disease control rate; ECG, electrocardiogram; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; MTD, maximum tolerated dose; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; SOC, standard of care; SpO2, peripheral capillary oxygen saturation.
Reference: ClinicalTrials.gov. 2260-001. Available at https://clinicaltrials.gov/study/NCT06248411. Accessed May 14, 2026.