Study of AUBE00 in Patients With Solid Tumors
- 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.
- Short title
- Study of AUBE00 in Patients With Solid Tumors
- Official title
- A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2029-12-31
- First posted
- 2025-06-22
- Registry last updated
- 2026-09-29
- Primary completion date
- 2029-12-31
- Start date
- 2025-06-05
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Chugai Pharmaceutical
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07030959
- ClinicalTrials.gov ID
- NCT07030959
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
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)
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.)
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
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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
- 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