A Study of KK2269 in Adult Participants With Solid Tumors

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266299
• Other study ID #: 2269-001
• Status: Recruiting
• Phase: Phase 1
• Start date: January 25, 2024
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: Kyowa Kirin Co., Ltd.
• Phone: +81-3-5205-7200
• Email: clinical.info.jp[@]kyowakirin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Solid Tumor
• Esophageal Adenocarcinoma
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Metastatic Solid Tumor
• Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• KK2269
KK2269 administered intravenously
• Docetaxel
antineoplastic drug administered intravenously

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East	Kashiwa City	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Experiencing Dose-limiting Toxicity		21 days after first dose
Primary	Number of Adverse Events		From signing of ICF through study completion, an average of 1 year