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NCT07030959From ClinicalTrials.govRecruiting

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

  • Solid Tumors

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Chugai Pharmaceutical
Enrolment target
130
Started
5 June 2025
Main results due
31 December 2029
Study sites
5
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(5)

  • 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

Showing 5 of 5 sites. 5 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07030959. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Study of AUBE00 in Patients With Solid Tumors | Trialion