Study of AUBE00 in Patients With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2030-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Dose Escalation part

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

Group Type EXPERIMENTAL

AUBE00

Intervention Type DRUG

AUBE00 as an oral administration

Part B: Expansion part

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

Group Type EXPERIMENTAL

AUBE00

Intervention Type DRUG

AUBE00 as an oral administration

Interventions

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AUBE00

AUBE00 as an oral administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No