A Phase 1, Open-label, Dose-escalation Study Evaluating Safety and Tolerability of Intravenous KK2269 Alone and With Docetaxel in Adults With Solid Tumors

What this Trial Is About

Researchers are evaluating KK2269, a new intravenous drug, in adult participants with advanced or metastatic solid tumors for which no standard therapy is available. This first-in-human, multicenter, open-label, non-randomized study has two parts. Part 1 focuses on assessing the safety and tolerability of KK2269 alone in various solid tumors. Part 2 enrolls participants with gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, esophageal adenocarcinoma, or non-small cell lung cancer (NSCLC) who have had at least one prior systemic therapy, to assess KK2269 combined with docetaxel. In Part 1, KK2269 is given by intravenous infusion at escalating doses. In Part 2, KK2269 is administered intravenously in combination with docetaxel, which is given intravenously every three weeks. Participants in both parts who refuse standard therapy are also eligible. The study aims to determine recommended dose levels and intervals for the combination treatment in Part 2. Participants will undergo safety and tolerability assessments, with the primary outcomes including the number of subjects experiencing dose-limiting toxicity within 21 days after the first dose and adverse events throughout about one year of study completion. Patients must have measurable disease and good performance status. The trial includes regular monitoring by investigators, with follow-up for safety and adverse events throughout the study period.

A Study of KK2269 in Adult Participants With Solid Tumors