AUBE00 for advanced or metastatic solid tumors with KRAS alterations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase I study tests AUBE00 across multiple centers to define safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity. Approximately 90–130 adults with locally advanced or metastatic solid tumors and confirmed KRAS alterations will be enrolled, including cohorts that receive AUBE00 alone or in combination with cetuximab. Eligible patients must be ≥18 years old with ECOG performance status 0–1 and have disease refractory to or lacking standard treatment options. The multinational design uses dose-escalation and expansion cohorts to identify safe doses and early signals of clinical activity.

Why it matters

Who can join: the full rules

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

Where it's running

• South Texas Accelerated Research Therapeutics (START) Midwest
  Grand Rapids, Michigan, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology Virginia
  Fairfax, Virginia, United States Recruiting
• National Cancer Center Hospital East
  Kashiwa, Chiba, Japan Recruiting
• National Cancer Center Hospital
  Chuo-ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Clinical trials information
• Email: clinical-trials@chugai-pharm.co.jp
• Phone: only use Email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.