NCT07030959 · Chugai Pharmaceutical
Study of AUBE00 in Patients With Solid Tumors
What this study is about
This is a first-in-human, Phase I, where both patients and doctors know the treatment given, conducted at multiple hospitals, multinational study, designed to evaluate the safety, tolerability, how the drug moves through the body (PK), how the drug affects the body (PD), immunogenicity, and anti-tumor activity of AUBE00 in patients with locally advanced or metastatic solid tumors.
View original scientific description
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.
Interventions
DRUG
AUBE00
AUBE00 as an oral administration
DRUG
Cetuximab
Cetuximab as an IV infusion
Primary outcome measures
Adverse events of AUBE00 [Part A, B, C]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Grand Rapids, Michigan
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations