A Study of KK2269 in Adult Participants With Solid Tumors
- Conditions
- Metastatic Solid TumorEsophageal AdenocarcinomaAdvanced Solid TumorGastroesophageal Junction AdenocarcinomaNon Small Cell Lung CancerGastric Adenocarcinoma
- Interventions
- Registration Number
- NCT06266299
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 KK2269 KK2269 will be administered at each dose level, intravenous infusion. Part 2 KK2269 KK2269 will be administered at each dose level intravenously in combination with docetaxel. Docetaxel will be administered intravenously (Q3W). Part 2 Docetaxel KK2269 will be administered at each dose level intravenously in combination with docetaxel. Docetaxel will be administered intravenously (Q3W).
- Primary Outcome Measures
Name Time Method Number of Subjects Experiencing Dose-limiting Toxicity 21 days after first dose Number of Adverse Events From signing of ICF through study completion, an average of 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
City Of Hope
🇺🇸Duarte, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Aichi Cancer Center
🇯🇵Nagoya city, Aichi, Japan
Cancer Institute Hospital of JFCR
🇯🇵Koto-Ku, Tokyo, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa City, Chiba, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan