RecruitingPhase 1NCT06248411

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

Sponsor

Kyowa Kirin Co., Ltd.

Enrollment

189 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced or Metastatic Solid Tumors

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called KK2260 in people with advanced or metastatic solid tumors (cancers that have spread and haven't responded to standard treatments). The trial is in early phases and aims to find the right dose and assess how safe the drug is. **You may be eligible if...** - You are 18 or older - You have a solid tumor that has not responded to or is not suitable for standard treatment - Your cancer can be measured on scans - You are willing to have a tumor biopsy - You are in reasonably good health with adequate organ function **You may NOT be eligible if...** - You have had recent major surgery (within 4 weeks) - Your cancer is not a solid tumor type - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems - You have active infections or autoimmune diseases requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKK2260

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.

DRUGKK2260

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.

Locations(13)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Saitama Cancer Center

Shinden, Saitama, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Kyushu Cancer Center

Fukuoka, Japan

Osaka International Cancer Institute

Osaka, Japan

View Full Details on ClinicalTrials.gov

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NCT06248411

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