AUBE00 for advanced or metastatic solid tumors with KRAS alterations
A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors
This trial will test AUBE00, alone and with cetuximab, in adults with advanced or metastatic KRAS‑altered solid tumors who have exhausted standard therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chugai Pharmaceutical Industry-sponsored |
| Drugs / interventions | cetuximab |
| Locations | 4 sites (Grand Rapids, Michigan and 3 other locations) |
| Trial ID | NCT07030959 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label Phase I study tests AUBE00 across multiple centers to define safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity. Approximately 90–130 adults with locally advanced or metastatic solid tumors and confirmed KRAS alterations will be enrolled, including cohorts that receive AUBE00 alone or in combination with cetuximab. Eligible patients must be ≥18 years old with ECOG performance status 0–1 and have disease refractory to or lacking standard treatment options. The multinational design uses dose-escalation and expansion cohorts to identify safe doses and early signals of clinical activity.
Who should consider this trial
Good fit: Adults (≥18) with locally advanced or metastatic solid tumors harboring KRAS alterations, ECOG 0–1, and who are refractory to or lack standard therapies are the intended participants.
Not a fit: Patients who are pregnant or breastfeeding, have active or untreated CNS metastases requiring therapy, significant uncontrolled cardiovascular disease, or who do not have KRAS alterations are unlikely to benefit from this trial.
Why it matters
Potential benefit: If AUBE00 is safe and active, it could provide a new treatment option that shrinks tumors or slows progression in patients with KRAS‑altered advanced solid tumors.
How similar studies have performed: This is a first-in-human study; while other KRAS‑targeted agents (for example KRAS G12C inhibitors) have shown benefit in specific mutation subtypes, the AUBE00 approach and its combination with cetuximab are novel and unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Grand Rapids, Michigan and 3 other locations
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- National Cancer Center Hospital East — Kashiwa, Chiba, Japan (Recruiting)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Clinical trials information
- Email: clinical-trials@chugai-pharm.co.jp
- Phone: only use Email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.