Solid TumorsPhase 1NCT07030959

Study of AUBE00 in Patients With Solid Tumors

A Phase 1 study testing AUBE00 and Cetuximab in people with Solid Tumors, run by Chugai Pharmaceutical at 5 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: AUBE00 and Cetuximab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 5 sitesin 2 countries
Study dates: 5 Jun 2025to 31 Dec 2029
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical trials information contact

only use Email

clinical-trials@chugai-pharm.co.jp

Country

City, postcode or hospital

Sites recruiting now only

5 sites in 2 countries

United States3 sites, 3 recruiting

NEXT Oncology Virginia
Fairfax, Virginia, 22031
Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Recruiting

Other trials in United States

Japan2 sites, 2 recruiting

National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Recruiting

Other trials in Japan

About this study

Official title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors

Conditions: Solid Tumors
Being tested: AUBE00, Cetuximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AUBE00Drug
AUBE00 as an oral administration
CetuximabDrug
Cetuximab as an IV infusion

Study groups in NCT07030959
Study group	Role	What they receive
Part A: Dose Escalation part of AUBE00 monotherapy with or without prophylactic management	Experimental	Patients will receive AUBE00 as an oral administration at escalated doses. Patients may also receive prophylactic management for treatment-related adverse events. Receives: Drug: AUBE00
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). Receives: Drug: AUBE00
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. Receives: Drug: AUBE00; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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.)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)

Secondary outcomes (15)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 202531 Dec 2029

First posted22 Jun 2025
Study start5 Jun 2025
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 130 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07030959
Sponsor's protocol ID: AUB101CT
Status last verified: Jul 2026
First submitted: 11 May 2025
Last updated: 29 Sep 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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).

Interested in taking part?

Clinical trials information

only use Email

clinical-trials@chugai-pharm.co.jp

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT07030959
Acronym / sponsor ID: AUB101CT
Conditions: Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 130 participants (estimated)
Lead sponsor: Chugai PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 5 Jun 2025 (actual)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 22 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Part A: Dose Escalation part of AUBE00 monotherapy with or without prophylactic management	Experimental	Drug: AUBE00Patients will receive AUBE00 as an oral administration at escalated doses. Patients may also receive prophylactic management for treatment-related adverse events.
Part B: Expansion part of AUBE00 monotherapy	Experimental	Drug: AUBE00Patients 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	Drug: AUBE00, Drug: CetuximabPatients will receive AUBE00 as an oral administration in combination with cetuximab as an IV infusion at escalated doses or the recommended dose level.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AUBE00AUBE00 as an oral administration	Drug	Part A: Dose Escalation part of AUBE00 monotherapy with or without prophylactic management, Part B: Expansion part of AUBE00 monotherapy, Part C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab
CetuximabCetuximab as an IV infusion	Drug	Part C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab

Primary outcome

Adverse events of AUBE00 [Part A, B, C]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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

15 secondary outcomes

Objective response of AUBE00 [Part A]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].
Anti-cetuximab antibodies of cetuximab [Part C]
Time frame: From Cycle 1 Day 1 until study completion, treatment discontinuation (up to approximately 55 months) [Part C].

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Individual participant dataSharing planned: Yes. 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).

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Clinical trials information contact

only use Email

clinical-trials@chugai-pharm.co.jp

Sponsor Chugai Pharmaceutical Co.Ltd study director

clinical-trials@chugai-pharm.co.jp

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AUBE00 and Cetuximab in people with Solid Tumors, run by Chugai Pharmaceutical at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical trials information (only use Email, clinical-trials@chugai-pharm.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events of AUBE00 [Part A, B, C] (time frame: From screening until study completion, treatment discontinuation or post-treatment follow up (up to approximately 55 months)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07030959.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.