RecruitingInterventionalPhase 1

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

NCT ID: NCT07030959Sponsor: Chugai PharmaceuticalLast updated: 2026-02-25

Summary

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.

Arms & interventions

DrugAUBE00
AUBE00 as an oral administration
DrugCetuximab
Cetuximab as an IV infusion

Outcome measures

Primary

Adverse events of AUBE00 [Part A, B, C]
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)
Time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Number of participants with changes in vital signs of AUBE00 [Part A, B, C]
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.)
Time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Number of participants with changes in clinical laboratory test of AUBE00 [Part A, B, C]
Change from baseline in clinical laboratory test
Time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Number of participants with changes in Electrocardiograms (ECGs) of AUBE00 [Part A, B, C]
Change from baseline in ECGs (QT interval)
Time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Maximum tolerated dose (MTD) of AUBE00 [Part A, C]
Incidence and nature of dose-limiting toxicities (DLTs)
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]
Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part A]
Tmax of AUBE00
Time frame: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Maximum plasma concentration (Cmax) of AUBE00 [Part A]
Cmax of AUBE00
Time frame: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Elimination half-life (t1/2) of AUBE00 [Part A]
t1/2 of AUBE00
Time frame: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Area under the plasma concentration-time curve (AUC) of AUBE00 [Part A]
AUC of AUBE00
Time frame: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Objective response of AUBE00 [Part B, C]
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
Time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)

Secondary

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)
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)
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)
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)
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)
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)
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].
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].
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].
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].
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].
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].
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].
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].
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].

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (2)

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, 49546

Recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting