Clinical Trials in the USA / NCT07030959
Recruiting
Phase 1
Study of AUBE00 in Patients With Solid Tumors
NCT07030959 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Solid Tumors
Investigational drug(s) / intervention(s)
AUBE00Cetuximab →
AUBE00: AUBE00 as an oral administration
Cetuximab: Cetuximab as an IV infusion
Study 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
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
Primary outcome measure(s)
- Adverse events of AUBE00 [Part A, B, C] — 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) - Number of participants with changes in vital signs of AUBE00 [Part A, B, C] — 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.) - Number of participants with changes in clinical laboratory test of AUBE00 [Part A, B, C] — From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Change from baseline in clinical laboratory test - Number of participants with changes in Electrocardiograms (ECGs) of AUBE00 [Part A, B, C] — From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)
Change from baseline in ECGs (QT interval) - Maximum tolerated dose (MTD) of AUBE00 [Part A, C] — 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) - Time to reach maximum plasma concentration (Tmax) of AUBE00 [Part A] — From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Tmax of AUBE00 - Maximum plasma concentration (Cmax) of AUBE00 [Part A] — From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
Cmax of AUBE00 - Elimination half-life (t1/2) of AUBE00 [Part A] — From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
t1/2 of AUBE00 - Area under the plasma concentration-time curve (AUC) of AUBE00 [Part A] — From Cycle 0 Day 1 until study completion, treatment discontinuation (up to approximately 55 months)
AUC of AUBE00 - Objective response of AUBE00 [Part B, C] — 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
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| South Texas Accelerated Research Therapeutics (START) Midwest | Grand Rapids | Michigan | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| NEXT Oncology Virginia | Fairfax | Virginia | Recruiting |
| National Cancer Center Hospital East | Kashiwa | Chiba | Recruiting |
| National Cancer Center Hospital | Chuo-ku | Tokyo | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07030959 on ClinicalTrials.gov ↗ ← All trials in the USA