A Phase 1, Multicenter, Open-label, Dose-escalation Study Evaluating the Safety and Tolerability of Intravenous KK2269 Monotherapy and Combination Therapy With Docetaxel in Adult Participants With Solid Tumors
Part 1: Monotherapy in adults with advanced/metastatic solid tumors for which no standard therapy exists
Primary objective
- To assess the safety and tolerability of KK2269
Part 2: Combination therapy with docetaxel once every 3 weeks in adults with gastric, GEJ, or esophageal adenocarcinomas or NSCLC who have received ≥1 prior systemic therapy
Primary objectives
- To assess the safety and tolerability of KK2269 in combination with docetaxel
- To determine the recommended dose(s) and dosing interval(s) of KK2269 in combination with docetaxel for subsequent studies
Primary Outcome Measures
- The number of patients who experience a dose-limiting toxicity within 21 days after the first dose of KK2269
- The number of adverse events experienced from study entry to completion
CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group Performance Status; GEJ, gastroesophageal junction; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; NSCLC, non-small cell lung cancer; RECIST, Response Evaluation Criteria in Solid Tumors.
Reference: ClinicalTrials.gov. 2269-001. Available at https://clinicaltrials.gov/study/NCT06266299. Accessed May 14, 2026.