NCT07030959PHASE1Recruiting
Study of AUBE00 in Patients With Solid Tumors
Chugai Pharmaceutical
Start Date
6/5/2025
Completion Date
12/31/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
AUBE00
DRUG
Cetuximab
Conditions
Solid Tumors
Locations
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan 49546
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan