NCT07030959 Study of AUBE00 in Patients With Solid Tumors
| NCT ID | NCT07030959 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chugai Pharmaceutical |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-06-05 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2025-06-05 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Sponsor Chugai Pharmaceutical Co.Ltd
STUDY DIRECTOR
clinical-trials@chugai-pharm.co.jp
Frequently Asked Questions
Who can join the NCT07030959 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07030959 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07030959 currently recruiting?
Yes, NCT07030959 is actively recruiting participants. Contact the research team at clinical-trials@chugai-pharm.co.jp for enrollment information.
Where is the NCT07030959 trial being conducted?
This trial is being conducted at Grand Rapids, United States, Houston, United States, Kashiwa, Japan, Chuo-ku, Japan.
Who is sponsoring the NCT07030959 clinical trial?
NCT07030959 is sponsored by Chugai Pharmaceutical. The principal investigator is Sponsor Chugai Pharmaceutical Co.Ltd at clinical-trials@chugai-pharm.co.jp. The trial plans to enroll 130 participants.