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Study of AUBE00 in Patients With Solid Tumors

RecruitingPhase 1

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

Sponsor: Chugai Pharmaceutical · Participants: 130 · Started: Jun 5, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07030959

Locations in the U.S.

MichiganSouth Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids
TexasThe University of Texas MD Anderson Cancer Center, Houston
VirginiaNEXT Oncology Virginia, Fairfax

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.