Recruiting
Phase 1

AUBE00

Sponsor:

Chugai Pharmaceutical

Code:

NCT07030959

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AUBE00

Cetuximab

Study Details

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

Study ID

NCT07030959

Start date

Jun 5, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Dose Escalation part of AUBE00 monotherapy with or without prophylactic management

Patients will receive AUBE00 as an oral administration at escalated doses. Patients may also receive prophylactic management for treatment-related adverse events.

experimental: Part B: Expansion part of AUBE00 monotherapy

Patients will receive AUBE00 as an oral administration at multiple dose levels determined to be safe (including MTD).

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

Patients will receive AUBE00 as an oral administration in combination with cetuximab as an IV infusion at escalated doses or the recommended dose level.

Interventions

AUBE00

AUBE00 as an oral administration

Cetuximab

Cetuximab as an IV infusion

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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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] ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Clinical trials information

only use Emailclinical-trials@chugai-pharm.co.jp

Locations

South Texas Accelerated Research Therapeutics (START) Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Chugai Pharmaceutical

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Chugai Pharmaceutical on 2026-07-20.