רדאר קליני AI | ||
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הניסוי הקליני NCT07030959 עבור גידולים מוצקים הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
צ'וגאי פרמצבטיקהStudy of AUBE00 in Patients With Solid Tumors שלב I 130 ראשון בבני אדם תווית פתוחה
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT07030959 מתקיים כדי לבדוק את טיפול עבור גידולים מוצקים. זהו מחקר שלב I מסוג התערבותי שנמצא כעת במצב מגייס. המחקר התחיל ב-5 ביוני 2025 ומתוכנן לכלול 130 משתתפים. המחקר מנוהל על ידי צ'וגאי פרמצבטיקה וצפוי להסתיים ב-31 בדצמבר 2029. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-25 בפברואר 2026.
סיכום קצר
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.
כותרת רשמית
A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors
מצבים רפואיים
גידולים מוצקיםמזהי מחקר נוספים
- AUB101CT
מספר NCT
תחילת המחקר (בפועל)
2025-06-05
עדכון אחרון שפורסם
2026-02-25
סיום המחקר (מוערך)
2029-12-31
משתתפים (מתוכנן)
130
סוג המחקר
התערבותי
שלב
שלב I
סטטוס
מגייס
מטרה ראשית
טיפול
הקצאת טיפול
לא אקראי
דגם מתערב
שיוך רצף
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיPart A: Dose Escalation part of AUBE00 monotherapy Patients will receive AUBE00 as an oral administration at escalated doses. | AUBE00 AUBE00 as an oral administration |
ניסיPart 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 |
ניסיPart 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 |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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) |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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]. |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
- 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
צ'וגאי פרמצבטיקהאיש קשר מרכזי למחקר
איש קשר: Clinical trials information, only use Email, [email protected]
4 מיקומי המחקר ב-2 מדינות
Michigan
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan, 49546, United States
מגייס
Texas
The University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States
מגייס
Chiba
National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan
מגייס
Tokyo
National Cancer Center Hospital, Chuo-ku, Tokyo, 104-0045, Japan
מגייס