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
This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269. In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies. In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.
⁃ Patients who are ≥ 18 years old at the time of informed consent
• Patients who have disease measurable by RECIST v1.1
• Patients with an ECOG PS of 0 or 1
• Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator
• The specified periods have passed respectively after the completion of previous cancer treatments as of the date of enrollment
• Patients who agree to use a medically effective method of contraception
‣ Key Additional Inclusion Criterion for Part 1:
‣ •Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor
⁃ Patients with histological or cytological evidence of any of the following disease:
• Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma
• NSCLC
• Patients who are suitable for docetaxel treatment