NCT06248411

A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors

A Phase 1, Uncontrolled, Open-label, Non-randomized, Dose-escalation Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors, Followed by an Uncontrolled, Non-randomized Study and an Uncontrolled, Randomized Study in Patients With Esophageal Squamous Cell Carcinoma or Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 189 (estimated)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer type). In Part 1b and Part 2, at least two dosing regimens and two dosing regimens by cancer type, respectively, will be selected, and the safety, tolerability, and efficacy of each regimen will be evaluated.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	KK2260	KK2260 will be administered intravenously at several dose levels, and after determining MTD, multiple dose regimens will be evaluated in multiple cancer types to target.
DRUG	KK2260	KK2260 will be administered intravenously at several dose levels, and after determining MTD, multiple dose regimens will be evaluated in multiple cancer types to target.

Timeline

• Start date: 2023-11-01
• Primary completion: 2029-10-31
• Completion: 2030-04-30
• First posted: 2024-02-08
• Last updated: 2026-03-18

Locations

13 sites across 1 country: Japan