Study of AUBE00 in Patients With Solid Tumors

NCT07030959 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AUB101CT
• Study Type: interventional
• Target: 130
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (10)

• 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)

Secondary Outcomes (15)

• Objective response of AUBE00 [Part A]

  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]

  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]

  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]

  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]

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

Study Arms (3)

Part A: Dose Escalation part of AUBE00 monotherapy

EXPERIMENTAL

Patients will receive AUBE00 as an oral administration at escalated doses.

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).

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.

Drug: AUBE00; Drug: Cetuximab

Interventions

AUBE00 DRUG

AUBE00 as an oral administration

Part A: Dose Escalation part of AUBE00 monotherapy; Part B: Expansion part of AUBE00 monotherapy; Part C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab

Cetuximab DRUG

Cetuximab as an IV infusion

Part C: Dose-Escalation and Expansion part of AUBE00 in combination with Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (4)

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sponsor Chugai Pharmaceutical Co.Ltd

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Central Study Contacts

Clinical trials information

CONTACT

only use Email; clinical-trials@chugai-pharm.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: June 22, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

JP (2); US (2)