A Study of KK2269 in Adult Participants With Solid Tumors
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
1 other identifier
interventional
101
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2024
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2024
CompletedFirst Submitted
Initial submission to the registry
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
January 28, 2026
January 1, 2026
5.1 years
February 5, 2024
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Part 1
EXPERIMENTALKK2269 will be administered at each dose level, intravenous infusion.
Part 2
EXPERIMENTALKK2269 will be administered at each dose level intravenously in combination with docetaxel. Docetaxel will be administered intravenously (Q3W).
Interventions
Eligibility Criteria
You may qualify if:
- 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 at the time of the first dose of KK2269
- Patients who agree to use a medically effective method of contraception
- 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
You may not qualify if:
- Patients with an uncontrolled or serious intercurrent illness
- Patients with known active central nervous system metastasis
- Patients with a history of ≥ Grade 3 allergic reaction to any antibody drug
- Patients with a history of autoimmune disease
- Patients with a history of HIV, HBV, or HCV at screening
- Patients who have a history of primary immunodeficiency
- Patients with a history of treatment with docetaxel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyowa Kirin, Inc.collaborator
- Kyowa Kirin Co., Ltd.lead
Study Sites (11)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
City Of Hope National Medical Center
Duarte, California, 91010, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Washington University
St Louis, Missouri, 63110, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Washington
Seattle, Washington, 98195, United States
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, 135-8550, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2024
First Posted
February 20, 2024
Study Start
January 18, 2024
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.