RecruitingPhase 1NCT07030959

Study of AUBE00 in Patients With Solid Tumors

A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors


Sponsor

Chugai Pharmaceutical

Enrollment

130 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors.The total number of patients in this study will be approximately 90 to 130.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AUBE00 and a drug called Cetuximab for people with solid tumors. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

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

DRUGAUBE00

AUBE00 as an oral administration

DRUGCetuximab

Cetuximab as an IV infusion


Locations(4)

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07030959


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