Study of KK2269 for Advanced Solid Tumors

This study is testing a new drug called KK2269 for adults with advanced or metastatic solid tumors (cancers that have spread). It's the first time KK2269 is being given to people. The study has two parts. In Part 1, researchers will look at the safety of KK2269 by itself. In Part 2, they will study KK2269 combined with another cancer drug called Docetaxel in people with specific cancers like stomach (gastric), gastroesophageal junction (GEJ), or esophageal adenocarcinoma. The main goal is to see how safe KK2269 is, both alone and with Docetaxel, and to find the best dose. You may be able to join if you are 18 or older, have a measurable tumor, and a good general health status. The current recruitment status is unclear.

Study design
This is a multicenter, open-label (meaning you and your doctors will know what treatment you are receiving), non-randomized study. It is a dose-escalation study, meaning participants will receive increasing doses to find the safest and most effective amount. The planned enrollment is 101 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for about one year, from when you sign the consent form until the study is complete. Dose-limiting side effects will be checked for 21 days after your first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06266299

A Study of KK2269 in Adult Participants With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kyowa Kirin Co., Ltd.
~101 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:KK2269Docetaxel

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Subjects Experiencing Dose-limiting Toxicity
Measured over 21 days after first dose
+1 more outcome measured
Advanced Solid Tumor
Metastatic Solid Tumor
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
Non Small Cell Lung Cancer
11 sites across 9 states
California2
Tokyo2
Arizona1
Florida1
Missouri1
Texas1
Washington1
Aichi-ken1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:

Exclusion

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
  • Number of Subjects Experiencing Dose-limiting Toxicity21 days after first dose
  • Number of Adverse EventsFrom signing of ICF through study completion, an average of 1 year