> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-aube00-in-patients-with-solid-tumors-277b3056-f2de-49fb-a4d2-143200289bfa > Record changed: 2026-11-04 # Study of AUBE00 in Patients With Solid Tumors NCT07030959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) Participants 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) Lead sponsor Chugai Pharmaceutical Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) Start date 2025-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Short title** Study of AUBE00 in Patients With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Official title** A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Dates **Completion date** 2029-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **First posted** 2025-06-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Registry last updated** 2026-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Primary completion date** 2029-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Start date** 2025-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Size and sites **Participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Planned participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Lead sponsor** Chugai Pharmaceutical Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Identifiers **Registry ID** NCT07030959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **ClinicalTrials.gov ID** NCT07030959 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Outcomes ### Primary outcomes 1. Adverse events of AUBE00 \[Part A, B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) 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) 2. Number of participants with changes in vital signs of AUBE00 \[Part A, B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) 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.) 3. Number of participants with changes in clinical laboratory test of AUBE00 \[Part A, B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) Change from baseline in clinical laboratory test 4. Number of participants with changes in Electrocardiograms (ECGs) of AUBE00 \[Part A, B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) Change from baseline in ECGs (QT interval) 5. Maximum tolerated dose (MTD) of AUBE00 \[Part A, C\] Timeframe: 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) \[Part C\] Incidence and nature of dose-limiting toxicities (DLTs) 6. Time to reach maximum plasma concentration (Tmax) of AUBE00 \[Part A\] Timeframe: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) Tmax of AUBE00 7. Maximum plasma concentration (Cmax) of AUBE00 \[Part A\] Timeframe: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) Cmax of AUBE00 8. Elimination half-life (t1/2) of AUBE00 \[Part A\] Timeframe: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) t1/2 of AUBE00 9. Area under the plasma concentration-time curve (AUC) of AUBE00 \[Part A\] Timeframe: From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) AUC of AUBE00 10. Objective response of AUBE00 \[Part B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) 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 ### Secondary outcomes 1. Objective response of AUBE00 \[Part A\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) Objective response, defined as a confirmed CR or PR as the best overall response per RECIST v1.1 as determined by the Investigator 2. Disease control of AUBE00 \[Part A, B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) Disease control, defined as a confirmed CR, PR, or stable disease (SD) per RECIST v1.1 as determined by the Investigator 3. Duration of response (DoR) of AUBE00 \[Part A, B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) 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 4. Progression free survival (PFS) of AUBE00 \[Part A, B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) 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 5. Anti-AUBE00 antibodies of AUBE00 \[Part A, B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) Incidence of anti-AUBE00 antibodies 6. Overall survival (OS) of AUBE00 \[Part B, C\] Timeframe: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months) OS, defined as the time from the date of first study treatment to death due to any cause 7. Time to reach maximum plasma concentration (Tmax) of AUBE00 \[Part B, C\] Timeframe: 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) \[Part C\]. Tmax of AUBE00 8. Maximum plasma concentration (Cmax) of AUBE00 \[Part B, C\] Timeframe: 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) \[Part C\]. Cmax of AUBE00 9. Elimination half-life (t1/2) of AUBE00 \[Part B, C\] Timeframe: 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) \[Part C\]. t1/2 of AUBE00 10. Area under the plasma concentration-time curve (AUC) of AUBE00 \[Part B, C\] Timeframe: 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) \[Part C\]. AUC of AUBE00 11. Time to reach maximum serum concentration (Tmax) of cetuximab \[Part C\] Timeframe: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) \[Part C\]. Tmax of cetuximab 12. Maximum serum concentration (Cmax) of cetuximab \[Part C\] Timeframe: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) \[Part C\]. Cmax of cetuximab 13. Elimination half-life (t1/2) of cetuximab \[Part C\] Timeframe: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) \[Part C\]. t1/2 of cetuximab 14. Area under the serum concentration-time curve (AUC) of cetuximab \[Part C\] Timeframe: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) \[Part C\]. AUC of cetuximab 15. Anti-cetuximab antibodies of cetuximab \[Part C\] Timeframe: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) \[Part C\]. Incidence of anti-cetuximab antibodies Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Sites - South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United StatesRecruiting - The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - NEXT Oncology VirginiaFairfax, United StatesRecruiting - National Cancer Center Hospital EastKashiwa, JapanRecruiting - National Cancer Center HospitalChuo-ku, JapanRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07030959) ## Related records ### Drugs (1) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) ### Lead sponsors (1) - [Chugai Pharmaceutical](https://trialight.com/data/company/chugai-pharmaceutical-11eb5042-dac0-454a-ac79-65503b8565f7.md) ### Targets (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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