A Study of KK2269 in Adult Participants With 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 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 Overview

• Status: Recruiting
• Conditions: Gastric Adenocarcinoma; Non Small Cell Lung Cancer; Advanced Solid Tumor; Metastatic Solid Tumor; Esophageal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: KK2269; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Estimated): 71
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kyowa Kirin, Inc.; Phone Number: 609-919-1100; Email: kkd.clintrial.82@kyowakirin.com
• Study Contact Backup: Name: Kyowa Kirin Co., Ltd.; Phone Number: +81-3-5205-7200; Email: clinical.info.jp@kyowakirin.com

Study Locations

• Japan
  • Chiba
    • Kashiwa City, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; KK2269 will be administered at each dose level, intravenous infusion.	Drug: KK2269; KK2269 administered intravenously
Experimental: Part 2; KK2269 will be administered at each dose level intravenously in combination with docetaxel. Docetaxel will be administered intravenously (Q3W).	Drug: KK2269; KK2269 administered intravenously; Drug: Docetaxel; antineoplastic drug administered intravenously; Other Names: Docetaxel Hydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects Experiencing Dose-limiting Toxicity	21 days after first dose
Number of Adverse Events	From signing of ICF through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Kyowa Kirin, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: 2269-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No