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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- AUBE00 (drug)
- Cetuximab (drug)
Sponsor: Chugai Pharmaceutical · Participants: 130 · Started: Jun 5, 2025
Contact the study team
- Clinical trials information · Phone: only use Email
Official record on ClinicalTrials.gov — NCT07030959
Locations in the U.S.
| Michigan | South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids |
| Texas | The University of Texas MD Anderson Cancer Center, Houston |
| Virginia | NEXT Oncology Virginia, Fairfax |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.