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NCT07030959PHASE1Recruiting

Study of AUBE00 in Patients With Solid Tumors

Chugai Pharmaceutical

Start Date

6/5/2025

Completion Date

12/31/2029

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

AUBE00

DRUG

Cetuximab

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Conditions

Solid Tumors

Locations

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan 49546

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045

Japan