KK2269
DrugKK2269 administered intravenously
NCT Number: NCT06266299
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Aichi Cancer Center, Nagoya, Aichi-ken, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
•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 (Only patients with NSCLC will be enrolled in the expansion part)
•Patients who are suitable for docetaxel treatment
KK2269 administered intravenously
antineoplastic drug administered intravenously
Other names: Docetaxel Hydrate
Time frame: 21 days after first dose
Time frame: From signing of ICF through study completion, an average of 1 year
Contact information is provided by the study sponsor or research team.
Kyowa Kirin Co., Ltd.
CONTACT
Kyowa Kirin, Inc.
CONTACT
Kyowa Kirin Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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