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RECRUITING Phase 1 ClinicalTrials.gov

Study of AUBE00 in Patients With Solid Tumors

Sponsor: Chugai Pharmaceutical • ClinicalTrials.gov ID: NCT07030959

Registry updated: 2026-09-29
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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

  • AUBE00 (Drug)
    AUBE00 as an oral administration
  • Cetuximab (Drug)
    Cetuximab as an IV infusion

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

Conditions

Solid Tumors

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record