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RECRUITING
NCT07030959
PHASE1

Study of AUBE00 in Patients With Solid Tumors

Sponsor: Chugai Pharmaceutical

View on ClinicalTrials.gov

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.

Official title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of AUBE00 in Patients With Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-06-05

Completion Date

2029-12-31

Last Updated

2026-02-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

AUBE00

AUBE00 as an oral administration

DRUG

Cetuximab

Cetuximab as an IV infusion

Locations (4)

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan