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RECRUITING
NCT06266299
PHASE1

A Study of KK2269 in Adult Participants With Solid Tumors

Sponsor: Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

101

Start Date

2024-01-18

Completion Date

2029-03

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DRUG

KK2269

KK2269 administered intravenously

DRUG

Docetaxel

antineoplastic drug administered intravenously

Locations (11)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

City Of Hope National Medical Center

Duarte, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Washington University

St Louis, Missouri, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Washington

Seattle, Washington, United States

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, Japan