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NCT Number: NCT06266299

A Study of KK2269 in Adult Participants With Solid Tumors

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

KK2269

Drug

KK2269 administered intravenously

docetaxel

Drug

antineoplastic drug administered intravenously

Other names: Docetaxel Hydrate

Primary outcomes

  1. Number of Subjects Experiencing Dose-limiting Toxicity

    Time frame: 21 days after first dose

  2. Number of Adverse Events

    Time frame: From signing of ICF through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Kyowa Kirin Co., Ltd.

CONTACT

[email protected]

+81-3-5205-7200

Kyowa Kirin, Inc.

CONTACT

[email protected]

609-919-1100

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Collaborators

  • Kyowa Kirin, Inc.

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 20, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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