Study of AUBE00 in Patients With Solid Tumors

Chugai Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: AUBE00

Study type: Interventional

Funder types: Industry

Identifiers

NCT07030959

AUB101CT

Details and patient eligibility

About

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 70 to 100.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Part A: Dose Escalation part

Experimental group

Description:

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

Treatment:

Drug: AUBE00

Part B: Expansion part

Experimental group

Description:

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

Treatment:

Drug: AUBE00