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NCT Number: NCT07030959

Study of AUBE00 in Patients With Solid Tumors

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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AUBE00

Drug

AUBE00 as an oral administration

Cetuximab

Drug

Cetuximab as an IV infusion

Primary outcomes

  1. 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)

  2. 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.)

  3. 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

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Secondary outcomes

  1. Objective response of AUBE00 [Part A]

    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 CR or PR as the best overall response per RECIST v1.1 as determined by the Investigator

  2. Disease control 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)

    Disease control, defined as a confirmed CR, PR, or stable disease (SD) per RECIST v1.1 as determined by the Investigator

  3. Duration of response (DoR) 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)

    DoR, defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression per RECIST v1.1 as determined by the Investigator or death due to any cause, whichever occurs first

  4. Progression free survival (PFS) 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)

    PFS, defined as the time from the first study treatment to the first occurrence of disease progression per RECIST v1.1 as determined by the Investigator or death due to any cause, whichever occurs first

  5. Anti-AUBE00 antibodies 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 of anti-AUBE00 antibodies

  6. Overall survival (OS) of AUBE00 [Part B, C]

    Time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)

    OS, defined as the time from the date of first study treatment to death due to any cause

  7. Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part B, C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    Tmax of AUBE00

  8. Maximum plasma concentration (Cmax) of AUBE00 [Part B, C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    Cmax of AUBE00

  9. Elimination half-life (t1/2) of AUBE00 [Part B, C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)[Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    t1/2 of AUBE00

  10. Area under the plasma concentration-time curve (AUC) of AUBE00 [Part B, C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)[Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    AUC of AUBE00

  11. Time to reach maximum serum concentration (Tmax) of cetuximab [Part C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    Tmax of cetuximab

  12. Maximum serum concentration (Cmax) of cetuximab [Part C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    Cmax of cetuximab

  13. Elimination half-life (t1/2) of cetuximab [Part C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    t1/2 of cetuximab

  14. Area under the serum concentration-time curve (AUC) of cetuximab [Part C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    AUC of cetuximab

  15. Anti-cetuximab antibodies of cetuximab [Part C]

    Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

    Incidence of anti-cetuximab antibodies

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical trials information

CONTACT

[email protected]

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Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 22, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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