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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Dose Escalation part of AUBE00 monotherapy | Experimental | Patients will receive AUBE00 as an oral administration at escalated doses. |
|
| Part B: Expansion part of AUBE00 monotherapy | Experimental | Patients will receive AUBE00 as an oral administration at multiple dose levels determined to be safe (including MTD). |
|
| Part C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab | Experimental | Patients will receive AUBE00 as an oral administration in combination with cetuximab as an IV infusion at escalated doses or the recommended dose level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AUBE00 | Drug | AUBE00 as an oral administration |
|
| 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] |
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical trials information | Contact | only use Email | clinical-trials@chugai-pharm.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Pharmaceutical Co.Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Accelerated Research Therapeutics (START) Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Cetuximab | Drug | Cetuximab as an IV infusion |
|
| 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) |
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]. |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| National Cancer Center Hospital East | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
| National Cancer Center Hospital | Recruiting | Chuo-ku | Tokyo | 104-0045 | Japan |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |