Study of AUBE00 in Patients With Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChugai Pharmaceutical
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
AUBE00
DrugAUBE00 as an oral administration
Cetuximab
DrugCetuximab as an IV infusion
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: Part A: Dose Escalation part of AUBE00 monotherapy with or without prophylactic managementExperimental treatment 1 intervention
Group B: Part B: Expansion part of AUBE00 monotherapyExperimental treatment 1 intervention
Group C: Part C: Dose-Escalation and Expansion part of AUBE00 in combination with CetuximabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)2
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.)
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)3
Number of participants with changes in clinical laboratory test of AUBE00 [Part A, B, C]
Change from baseline in clinical laboratory test
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)4
Number of participants with changes in Electrocardiograms (ECGs) of AUBE00 [Part A, B, C]
Change from baseline in ECGs (QT interval)
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)Secondary outcomes
1
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
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)2
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
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)3
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
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)4
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
Time frame
From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)Sponsors and contacts
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Source ClinicalTrials.gov