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RECRUITINGPHASE1

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

NCT07030959•Chugai Pharmaceutical

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years at time of signing Informed Consent Form (ICF)
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Patients with Kirsten rat sarcoma (KRAS) alteration confirmed by local tests or central laboratory test (Details are defined for each part)
•Refractory or resistant to standard therapies or standard therapies are not available

Exclusion Criteria

•Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study or within 27 weeks after the last dose of AUBE00 or within 2 months after the last dose of cetuximab, whichever is longer.
•Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
•Significant cardiovascular disease, such as New York Heart Association (NYHA) Class II or greater cardiac disease, unstable angina, or myocardial infraction within the previous 6 months or unstable arrhythmias within the previous 3 months
•Patient with complications from a cerebrovascular disorder (such as subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, etc.) or a history of such complications within 6 months prior to enrollment

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

Key Dates

Start Date

June 5, 2025

Primary Completion Date

December 31, 2029

Completion Date

December 31, 2029

Last Updated

February 25, 2026

Enrollment

130

ESTIMATED participants

Conditions

Solid Tumors

Interventions

AUBE00

DRUG

Cetuximab

DRUG

Contacts

Clinical trials information

CONTACT

only use Email clinical-trials@chugai-pharm.co.jp

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of AUBE00 in Patients With Solid Tumors

Inclusion Criteria

Exclusion Criteria

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