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Study of AUBE00 in Solid Tumors

This study is testing a new oral drug called AUBE00 in people with advanced solid tumors. It's a first-in-human study, meaning it's one of the first times this drug is being given to people. Researchers want to see how safe AUBE00 is, how well your body handles it, and if it shows any signs of shrinking tumors. You might be eligible if you are 18 or older, have solid tumors that have not responded to standard treatments, and your tumor has a specific change called a KRAS alteration. The study will also look at side effects and changes in your vital signs and lab tests over time, up to about 55 months.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know which treatment you are receiving. It will involve approximately 90 to 130 participants across multiple locations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed from screening until the study ends, or you stop treatment, or during post-treatment follow-up, for up to approximately 55 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07030959

Study of AUBE00 in Patients With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Chugai Pharmaceutical
~130 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:AUBE00Cetuximab

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events of AUBE00 [Part A, B, C]
Measured over From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
+9 more outcomes measured

Conditions

Solid Tumors

Explore related trials

Solid NeoplasmGTPase KRas

Where it's being run

4 sites across 4 states
Michigan1
Texas1
Chiba1
Tokyo1

Study leadership

Who to contact

Clinical trials information
[email protected]
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Adverse events of AUBE00 [Part A, B, C]From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)

    Incidence, nature, and severity of adverse events (AEs), with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)

  • Number of participants with changes in vital signs of AUBE00 [Part A, B, C]From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)

    Change from baseline in vital signs (Includes respiratory rate, pulse oximetry, pulse rate, and systolic and diastolic blood pressure while the patient is in a seated or semi-recumbent position, and temperature.)

  • Number of participants with changes in clinical laboratory test of AUBE00 [Part A, B, C]From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)

    Change from baseline in clinical laboratory test

  • Number of participants with changes in Electrocardiograms (ECGs) of AUBE00 [Part A, B, C]From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)

    Change from baseline in ECGs (QT interval)

  • Maximum tolerated dose (MTD) of AUBE00 [Part A, C]From Cycle 0 Day 1 until Cycle 2 Day 1 (approximately 30 days) (Cycle 0: 6 to 9 days, Cycle 1 and beyond each Cycle: 21 days) [Part A]; From Cycle 1 Day 1 until Cycle 2 Day 1 (approximately 28 days) (Cycle 1 and beyond each Cycle: 28 days) [Part C]

    Incidence and nature of dose-limiting toxicities (DLTs)

  • Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part A]From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)

    Tmax of AUBE00

  • Maximum plasma concentration (Cmax) of AUBE00 [Part A]From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)

    Cmax of AUBE00

  • Elimination half-life (t1/2) of AUBE00 [Part A]From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)

    t1/2 of AUBE00

  • Area under the plasma concentration-time curve (AUC) of AUBE00 [Part A]From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)

    AUC of AUBE00

  • Objective response of AUBE00 [Part B, C]From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)

    Objective response, defined as a confirmed complete response (CR) or partial response (PR) as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the Investigator