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Recruiting
NCT07030959
Study of AUBE00 in Patients With Solid Tumors
Conditions: Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 130
Sponsor: Chugai Pharmaceutical
Location: South Texas Accelerated Research Therapeutics (START) Midwest Grand Rapids Michigan
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
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
Source: ClinicalTrials.gov (NCT07030959). StuddyBuddy aggregates publicly available trial information.