Study of AUBE00 in Patients With Solid Tumors
NCT07030959 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2026-02-25
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
Interventions
- DRUG
-
AUBE00
AUBE00 as an oral administration
- DRUG
-
Cetuximab as an IV infusion
Sponsors & Collaborators
-
Chugai Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Sponsor Chugai Pharmaceutical Co.Ltd · [email protected]
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-05
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
- FDA Drug
- Yes
Countries
- United States
- Japan
Study Locations
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