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Recruiting Phase 1 Interventional

A Study of KK2269 in Adult Participants With Solid Tumors

ClinicalTrials.gov ID: NCT06266299

Public ClinicalTrials.gov record NCT06266299. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 18, 2026, 9:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06266299
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Kyowa Kirin Co., Ltd.
Industry
Enrollment
101 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 17, 2024
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029
Last update posted
Sep 9, 2026

2024 – 2029

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Mayo Clinic Arizona Scottsdale Arizona 85259 Recruiting
City Of Hope National Medical Center Duarte California 91010 Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California 92663 Recruiting
Mayo Clinic Jacksonville Jacksonville Florida 32224 Recruiting
Washington University St Louis Missouri 63110 Recruiting
The University of Texas Southwestern Medical Center Dallas Texas 75390 Recruiting
University of Washington Seattle Washington 98195 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06266299, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 9, 2026 · Synced Sep 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06266299 live on ClinicalTrials.gov.

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