Testing KK2269 in adults with advanced 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
This study is testing a new treatment called KK2269 in adults with advanced solid tumors to see if it is safe and works better alone or with another drug called docetaxel.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 101 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kyowa Kirin Co., Ltd. Industry-sponsored |
| Locations | 11 sites (Scottsdale, Arizona and 10 other locations) |
| Trial ID | NCT06266299 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, multicenter, open-label, non-randomized, dose-escalation study of KK2269 in adults with advanced or metastatic solid tumors for which no standard therapy is available. The study consists of two parts: Part 1 focuses on assessing the safety and tolerability of KK2269 alone, while Part 2 evaluates KK2269 in combination with docetaxel in patients with specific types of adenocarcinomas who have previously undergone systemic therapy. Participants who refuse standard therapy are also eligible for enrollment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors, particularly gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC.
Not a fit: Patients with solid tumors that have effective standard therapies available may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have limited or no effective therapies.
How similar studies have performed: While this approach is novel, similar studies have shown promise in evaluating new treatments for advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
* Key Common Inclusion Criteria for Parts 1 and 2: * 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 * 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 * Key Additional Inclusion Criteria for Part 2: •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 * Key Common Exclusion Criteria for Parts 1 and 2: * 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 * Key Additional Exclusion Criterion For Part 2: * Patients with a history of treatment with docetaxel
Where this trial is running
Scottsdale, Arizona and 10 other locations
- Mayo Clinic Arizona — Scottsdale, Arizona, United States (Recruiting)
- City Of Hope National Medical Center — Duarte, California, United States (Recruiting)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Recruiting)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Washington University — St Louis, Missouri, United States (Recruiting)
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Aichi Cancer Center — Nagoya, Aichi-ken, Japan (Recruiting)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (Recruiting)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (Recruiting)
- Cancer Institute Hospital of JFCR — Koto-Ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Kyowa Kirin Co., Ltd.
- Email: clinical.info.jp@kyowakirin.com
- Phone: +81-3-5205-7200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.