Study of AUBE00 in Patients With Solid Tumors
Recruiting now · Phase 1
Conditions studied: Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT07030959
- Run by
- Chugai Pharmaceutical
- People needed
- 130
- Starts
- 2025-06-05
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (enrolling)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (enrolling)
Full record on ClinicalTrials.gov
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