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Clinical Trial NCT07030959 for Solid Tumors is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Chugai PharmaceuticalStudy of AUBE00 in Patients With Solid Tumors Phase 1 130 First-in-Human Open-Label
Clinical Trial NCT07030959 is designed to study Treatment for Solid Tumors. It is a Phase 1 interventional study that is recruiting, having started on 5 June 2025, with plans to enroll 130 participants. Led by Chugai Pharmaceutical, it is expected to complete by 31 December 2029. The latest data from ClinicalTrials.gov was last updated on 25 February 2026.
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.
Official Title
A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors
Conditions
Solid TumorsOther Study IDs
- AUB101CT
NCT ID Number
Start Date (Actual)
2025-06-05
Last Update Posted
2026-02-25
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
130
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart A: Dose Escalation part of AUBE00 monotherapy Patients will receive AUBE00 as an oral administration at escalated doses. | AUBE00 AUBE00 as an oral administration |
ExperimentalPart B: Expansion part of AUBE00 monotherapy Patients will receive AUBE00 as an oral administration at multiple dose levels determined to be safe (including MTD). | AUBE00 AUBE00 as an oral administration |
ExperimentalPart C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab Patients will receive AUBE00 as an oral administration in combination with cetuximab as an IV infusion at escalated doses or the recommended dose level. | AUBE00 AUBE00 as an oral administration Cetuximab Cetuximab as an IV infusion |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Adverse events of AUBE00 [Part A, B, C] | Incidence, nature, and severity of adverse events (AEs), with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Number of participants with changes in vital signs of AUBE00 [Part A, B, C] | Change from baseline in vital signs (Includes respiratory rate, pulse oximetry, pulse rate, and systolic and diastolic blood pressure while the patient is in a seated or semi-recumbent position, and temperature.) | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Number of participants with changes in clinical laboratory test of AUBE00 [Part A, B, C] | Change from baseline in clinical laboratory test | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Number of participants with changes in Electrocardiograms (ECGs) of AUBE00 [Part A, B, C] | Change from baseline in ECGs (QT interval) | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Maximum tolerated dose (MTD) of AUBE00 [Part A, C] | Incidence and nature of dose-limiting toxicities (DLTs) | From Cycle 0 Day 1 until Cycle 2 Day 1 (approximately 30 days) (Cycle 0: 6 to 9 days, Cycle 1 and beyond each Cycle: 21 days) [Part A]; From Cycle 1 Day 1 until Cycle 2 Day 1 (approximately 28 days) (Cycle 1 and beyond each Cycle: 28 days) [Part C] |
Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part A] | Tmax of AUBE00 | From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) |
Maximum plasma concentration (Cmax) of AUBE00 [Part A] | Cmax of AUBE00 | From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) |
Elimination half-life (t1/2) of AUBE00 [Part A] | t1/2 of AUBE00 | From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) |
Area under the plasma concentration-time curve (AUC) of AUBE00 [Part A] | AUC of AUBE00 | From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) |
Objective response of AUBE00 [Part B, C] | Objective response, defined as a confirmed complete response (CR) or partial response (PR) as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the Investigator | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective response of AUBE00 [Part A] | Objective response, defined as a confirmed CR or PR as the best overall response per RECIST v1.1 as determined by the Investigator | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Disease control of AUBE00 [Part A, B, C] | Disease control, defined as a confirmed CR, PR, or stable disease (SD) per RECIST v1.1 as determined by the Investigator | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Duration of response (DoR) of AUBE00 [Part A, B, C] | DoR, defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression per RECIST v1.1 as determined by the Investigator or death due to any cause, whichever occurs first | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Progression free survival (PFS) of AUBE00 [Part A, B, C] | PFS, defined as the time from the first study treatment to the first occurrence of disease progression per RECIST v1.1 as determined by the Investigator or death due to any cause, whichever occurs first | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Anti-AUBE00 antibodies of AUBE00 [Part A, B, C] | Incidence of anti-AUBE00 antibodies | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Overall survival (OS) of AUBE00 [Part B, C] | OS, defined as the time from the date of first study treatment to death due to any cause | From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) |
Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part B, C] | Tmax of AUBE00 | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Maximum plasma concentration (Cmax) of AUBE00 [Part B, C] | Cmax of AUBE00 | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Elimination half-life (t1/2) of AUBE00 [Part B, C] | t1/2 of AUBE00 | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)[Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Area under the plasma concentration-time curve (AUC) of AUBE00 [Part B, C] | AUC of AUBE00 | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)[Part B]. From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Time to reach maximum serum concentration (Tmax) of cetuximab [Part C] | Tmax of cetuximab | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Maximum serum concentration (Cmax) of cetuximab [Part C] | Cmax of cetuximab | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Elimination half-life (t1/2) of cetuximab [Part C] | t1/2 of cetuximab | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Area under the serum concentration-time curve (AUC) of cetuximab [Part C] | AUC of cetuximab | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Anti-cetuximab antibodies of cetuximab [Part C] | Incidence of anti-cetuximab antibodies | From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C]. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Chugai PharmaceuticalStudy Central Contact
Contact: Clinical trials information, only use Email, [email protected]
4 Study Locations in 2 Countries
Michigan
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
Recruiting
Texas
The University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States
Recruiting
Chiba
National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan
Recruiting
Tokyo
National Cancer Center Hospital, Chuo-ku, Tokyo, 104-0045, Japan
Recruiting